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OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01643772
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Oxycodone hydrochloride
Enrollment 61
Recruitment Details The study was conducted in phase I unit in two public hospitals, the first subject took the first dose study medication on 13May2011, the last subject took the last dose on 6Jul2012.
Pre-assignment Details The study has a 7-days screening phase, for the subject who meet all the inclusion and exclusion criteria was dosed without run-in or wash out period.
Arm/Group Title Oxycodone Hydrochloride Single Dose(5mg) Oxycodone Hydrochloride Single Dose(10mg) Oxycodone Hydrochloride Single Dose(20mg) Oxycodone Hydrochloride Multiple Dose
Hide Arm/Group Description Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Period Title: Overall Study
Started 15 15 15 16
Completed 15 15 15 14
Not Completed 0 0 0 2
Reason Not Completed
Protocol Violation             0             0             0             1
Adverse Event             0             0             0             1
Arm/Group Title Oxycodone Hydrochloride Single Dose(5mg) Oxycodone Hydrochloride Single Dose(10mg) Oxycodone Hydrochloride Single Dose(20mg) Oxycodone Hydrochloride Multiple Dose(10mg) Total
Hide Arm/Group Description Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 16 61
Hide Baseline Analysis Population Description
PP Population
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 15 participants 15 participants 14 participants 14 participants 58 participants
40.22  (4.90) 39.63  (6.21) 36.16  (8.68) 48.62  (7.87) 41.11  (8.14)
[1]
Measure Analysis Population Description: PP population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 14 participants 14 participants 58 participants
Female
8
  53.3%
8
  53.3%
5
  35.7%
7
  50.0%
28
  48.3%
Male
7
  46.7%
7
  46.7%
9
  64.3%
7
  50.0%
30
  51.7%
[1]
Measure Analysis Population Description: PP Population
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 14 participants 14 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
15
 100.0%
15
 100.0%
14
 100.0%
14
 100.0%
58
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: PP Population
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 15 participants 15 participants 14 participants 14 participants 58 participants
15 15 14 14 61
[1]
Measure Analysis Population Description: PP Population
1.Primary Outcome
Title AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
Hide Description To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed.
Time Frame blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: ng*hr*ml
Oxycondone(AUC0-t) Number Analyzed 15 participants 15 participants 14 participants
57.03  (14.62) 102.10  (23.94) 205.89  (58.03)
Oxycondone(AUC0-∞) Number Analyzed 15 participants 15 participants 14 participants
58.38  (15.41) 104.56  (25.16) 210.61  (59.89)
Noroxycodone(AUC0-t) Number Analyzed 14 participants 15 participants 14 participants
38.85  (9.61) 89.76  (29.13) 163.68  (43.29)
Noroxycodone(AUC0-∞) Number Analyzed 15 participants 15 participants 14 participants
41.93  (11.09) 99.15  (34.11) 178.61  (46.70)
Hydroxymorphine(AUC0-t) Number Analyzed 0 participants 1 participants 1 participants
3.12  (0) 3.79  (0)
Hydroxymorphine(AUC0-∞) Number Analyzed 15 participants 15 participants 14 participants
0  (0) 3.96  (0) 4.36  (0)
Normethoxymorphone(AUC0-t) Number Analyzed 14 participants 14 participants 14 participants
13.27  (10.43) 28.69  (26.39) 37.64  (17.51)
Normethoxymorphone(AUC0-∞) Number Analyzed 14 participants 14 participants 14 participants
15.07  (11.54) 33.31  (29.29) 43.85  (19.42)
2.Primary Outcome
Title Cmax,Clast for Participants Who Received a Single Dose
Hide Description To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Time Frame blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP population
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: ng*mL
Oxycodone(Cmax) Number Analyzed 15 participants 15 participants 14 participants
12.97  (2.67) 21.14  (4.58) 35.56  (14.18)
Noroxycodone(Cmax) Number Analyzed 15 participants 15 participants 14 participants
6.19  (2.15) 11.62  (2.79) 19.19  (5.88)
Hydroxymorphine(Cmax) Number Analyzed 15 participants 15 participants 14 participants
0.27  (0.12) 0.42  (0.20) 0.76  (0.29)
Normethoxymorphone(Cmax) Number Analyzed 15 participants 15 participants 14 participants
1.64  (1.52) 1.77  (1.46) 3.52  (1.75)
Oxycodone(Clast) Number Analyzed 15 participants 15 participants 14 participants
0.20  (0.11) 0.37  (0.20) 0.74  (0.30)
Noroxycodone(Clast) Number Analyzed 15 participants 15 participants 14 participants
0.32  (0.17) 0.89  (0.51) 1.56  (0.47)
Hydroxymorphine(Clast) Number Analyzed 0 participants 1 participants 1 participants
0.05  (0) 0.05  (0)
Normethoxymorphone(Clast) Number Analyzed 14 participants 14 participants 14 participants
0.16  (0.12) 0.36  (0.28) 0.49  (0.25)
3.Primary Outcome
Title Tmax,t1/2 for Participants Who Received a Single Dose
Hide Description To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Time Frame blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP popluation
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: hour
Oxycodone (Tmax) Number Analyzed 15 participants 15 participants 14 participants
0.98  (0.43) 0.80  (0.22) 0.73  (0.18)
Oxycodone (t1/2) Number Analyzed 15 participants 15 participants 14 participants
4.42  (0.70) 4.38  (0.57) 4.24  (0.52)
Noroxycodone (Tmax) Number Analyzed 15 participants 15 participants 14 participants
1.32  (1.36) 1.08  (0.82) 0.98  (0.64)
Noroxycodone (t1/2) Number Analyzed 15 participants 15 participants 14 participants
6.22  (1.18) 6.63  (1.47) 6.59  (0.61)
Hydroxymorphine(Tmax) Number Analyzed 15 participants 15 participants 14 participants
0.90  (0.32) 0.87  (0.33) 1.07  (0.94)
Hydroxymorphine (t1/2) Number Analyzed 0 participants 1 participants 1 participants
11.70  (0) 7.90  (0)
Normethoxymorphone(Tmax) Number Analyzed 15 participants 15 participants 14 participants
1.62  (1.38) 1.77  (1.46) 2.04  (1.84)
Normethoxymorphone(t1/2) Number Analyzed 14 participants 14 participants 14 participants
7.78  (1.71) 9.17  (1.93) 8.22  (2.28)
4.Primary Outcome
Title Clearance Rate for Participants Who Received a Single Dose
Hide Description To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Time Frame blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP popuplation
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: L*hour
Oxycodone (CL) Number Analyzed 15 participants 15 participants 14 participants
91.49  (24.45) 101.53  (27.54) 101.33  (25.16)
Noroxycodone (CL) Number Analyzed 15 participants 15 participants 14 participants
125.78  (28.40) 113.30  (40.85) 119.38  (31.09)
Hydroxymorphine(CL) Number Analyzed 0 participants 1 participants 1 participants
2525.30  (0) 4587.50  (0)
Normethoxymorphone(CL) Number Analyzed 14 participants 14 participants 14 participants
443.45  (192.68) 530.65  (368.02) 681.64  (736.51)
5.Primary Outcome
Title Vd for Participants Who Received a Single Dose
Hide Description To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Time Frame blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP population
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: L
Oxycodone Number Analyzed 15 participants 15 participants 14 participants
568.11  (118.51) 626.45  (115.70) 611.17  (137.94)
Noroxycodone Number Analyzed 15 participants 15 participants 14 participants
1119.22  (312.37) 1026.65  (230.16) 1138.72  (335.51)
Hydroxymorphine Number Analyzed 0 participants 1 participants 1 participants
42608.80  (0) 52264.20  (0)
Normethoxymorphone Number Analyzed 14 participants 14 participants 14 participants
5004.50  (2443.16) 7297.56  (5341.91) 7460.04  (5956.86)
6.Primary Outcome
Title ke for Participants Who Received a Single Dose
Hide Description To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.
Time Frame blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
PP population
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: h^-1
Oxycodone Number Analyzed 15 participants 15 participants 14 participants
0.16  (0.03) 0.16  (0.02) 0.17  (0.02)
Noroxycodone Number Analyzed 15 participants 15 participants 14 participants
0.12  (0.02) 0.11  (0.02) 0.11  (0.01)
Hydroxymorphine Number Analyzed 0 participants 1 participants 1 participants
0.06  (0) 0.09  (0)
Normethoxymorphone Number Analyzed 14 participants 14 participants 14 participants
0.09  (0.02) 0.08  (0.02) 0.10  (0.05)
7.Primary Outcome
Title AUCss for Participants Who Received Multiple Dose
Hide Description To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Time Frame Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.
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Hide Analysis Population Description
PP population
Arm/Group Title Oxycodone Hydrochloride Multiple Dose
Hide Arm/Group Description:
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng*hours*mL
Oxycodone Number Analyzed 14 participants
156.03  (72.07)
Noroxycodone Number Analyzed 14 participants
122.69  (39.02)
Hydroxymorphine Number Analyzed 7 participants
4.51  (1.40)
Normethoxymorphone Number Analyzed 14 participants
16.56  (8.34)
8.Primary Outcome
Title Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
Hide Description To calculate Css_min,Css_max and Css_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Time Frame Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.
Hide Outcome Measure Data
Hide Analysis Population Description
multiple dose group has 14 subjects
Arm/Group Title Oxycodone Hydrochloride Multiple Dose
Hide Arm/Group Description:
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/ml
Oxycodone(Css_min) Number Analyzed 14 participants
16.92  (8.71)
Noroxycodone(Css_min) Number Analyzed 14 participants
15.74  (5.58)
Hydroxymorphine(Css_min) Number Analyzed 7 participants
0.40  (0.20)
Normethoxymorphone(Css_min) Number Analyzed 14 participants
2.18  (1.02)
Oxycodone(Css_max ) Number Analyzed 14 participants
40.17  (15.38)
Noroxycodone(Css_max ) Number Analyzed 14 participants
26.71  (8.03)
Hydroxymorphine(Css_max ) Number Analyzed 14 participants
1.10  (0.47)
Normethoxymorphone(Css_max ) Number Analyzed 14 participants
3.65  (1.97)
Oxycodone(Css_av) Number Analyzed 14 participants
26.01  (12.01)
Noroxycodone(Css_av) Number Analyzed 14 participants
20.44  (6.50)
Hydroxymorphine(Css_av) Number Analyzed 14 participants
0.75  (0.24)
Normethoxymorphone(Css_av) Number Analyzed 14 participants
2.76  (1.39)
9.Primary Outcome
Title Tmax,t1/2 for Participants Who Received Multiple Dose
Hide Description To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Time Frame Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.
Hide Outcome Measure Data
Hide Analysis Population Description
multiple dose group has 14 subjects
Arm/Group Title Oxycodone Hydrochloride Multiple Dose
Hide Arm/Group Description:
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: hour
Oxycodone( Tmax) 1.35  (0.65)
Noroxycodone( Tmax) 1.51  (1.00)
Hydroxymorphine( Tmax) 1.49  (1.00)
Normethoxymorphone( Tmax) 1.86  (1.48)
Oxycodone(t1/2) 5.07  (1.47)
Noroxycodone(t1/2) 7.23  (1.92)
Hydroxymorphine(t1/2) 8.09  (2.60)
Normethoxymorphone(t1/2) 9.07  (1.96)
10.Primary Outcome
Title CL for Participants Who Received Multiple Dose
Hide Description To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Time Frame Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.
Hide Outcome Measure Data
Hide Analysis Population Description
multiple dose group has 14 subjects
Arm/Group Title Oxycodone Hydrochloride Multiple Dose
Hide Arm/Group Description:
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: L*hour
Oxycodone Number Analyzed 14 participants
73.54  (24.08)
Noroxycodone Number Analyzed 14 participants
90.66  (32.56)
Hydroxymorphine Number Analyzed 7 participants
2374.20  (597.75)
Normethoxymorphone Number Analyzed 14 participants
773.01  (431.19)
11.Primary Outcome
Title Fluctuation Index (DF) for Participants Who Received Multiple Dose
Hide Description To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.
Time Frame Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.
Hide Outcome Measure Data
Hide Analysis Population Description
multiple dose group has 14 subjects
Arm/Group Title Oxycodone Hydrochloride Multiple Dose
Hide Arm/Group Description:
Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/ml
Oxycodone Number Analyzed 14 participants
94.11  (32.64)
Noroxycodone Number Analyzed 14 participants
55.75  (23.54)
Hydroxymorphine Number Analyzed 7 participants
123.95  (57.22)
Normethoxymorphone Number Analyzed 14 participants
52.07  (37.68)
12.Primary Outcome
Title The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hide Description The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Time Frame Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: μg
Oxycondone(Pre-dose) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
Oxycondone(post dose0-2h) 25.69  (29.55) 54.55  (79.39) 108.57  (171.53)
Oxycondone(post dose2-4h) 64.24  (72.40) 172.38  (192.35) 316.07  (188.88)
Oxycondone(post dose4-8h) 64.93  (56.60) 169.28  (268.13) 165.45  (101.00)
Oxycondone(post dose8-12h) 56.07  (84.81) 78.48  (91.91) 71.07  (76.02)
Oxycondone(post dose12-24h) 40.30  (88.58) 36.12  (33.66) 67.92  (86.71)
Noroxycodone(Pre-dose) 0  (0) 0  (0) 0  (0)
Noroxycodone(post dose0-2h) 23.29  (39.94) 63.80  (83.33) 157.75  (229.32)
Noroxycodone(post dose2-4h) 105.53  (112.06) 346.22  (262.65) 784.70  (390.56)
Noroxycodone(post dose4-8h) 153.49  (124.65) 418.95  (527.24) 712.81  (417.09)
Noroxycodone(post dose8-12h) 139.45  (138.45) 212.68  (170.80) 360.37  (375.81)
Noroxycodone(post dose12-24h) 53.09  (41.21) 128.75  (90.37) 265.31  (400.05)
Hydroxymorphine(Pre-dose) 0  (0) 0  (0) 0  (0)
Hydroxymorphine(post dose0-2h) 0.51  (0.65) 0.94  (1.41) 2.89  (4.87)
Hydroxymorphine(post dose2-4h) 1.03  (1.03) 2.52  (3.02) 9.99  (7.14)
Hydroxymorphine(post dose4-8h) 1.72  (1.46) 5.80  (12.62) 5.85  (6.09)
Hydroxymorphine(post dose8-12h) 2.07  (3.39) 2.97  (4.02) 2.49  (2.62)
Hydroxymorphine(post dose12-24h) 2.31  (6.15) 1.67  (1.86) 2.90  (3.74)
Normethoxymorphone(Pre-dose) 0  (0) 0  (0) 0  (0)
Normethoxymorphone(post dose0-2h) 3.97  (6.96) 7.16  (11.48) 8.53  (13.63)
Normethoxymorphone(post dose2-4h) 15.44  (12.78) 23.53  (16.86) 40.29  (33.67)
Normethoxymorphone(post dose4-8h) 25.15  (33.82) 68.87  (131.24) 39.64  (23.90)
Normethoxymorphone(post dose8-12h) 28.59  (30.00) 30.17  (21.62) 48.38  (49.36)
Normethoxymorphone(post dose12-24h) 26.74  (30.33) 30.16  (34.28) 33.76  (31.67)
13.Primary Outcome
Title Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hide Description Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Time Frame post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: μg
Oxycondone(post dose0-2h) 25.69  (29.55) 54.55  (79.39) 108.57  (171.53)
Oxycondone(post dose2-4h) 89.93  (91.36) 226.92  (244.12) 424.64  (326.09)
Oxycondone(post dose4-8h) 154.86  (129.52) 396.20  (410.41) 590.08  (361.27)
Oxycondone(post dose8-12h) 210.92  (203.25) 474.68  (455.83) 661.15  (338.34)
Oxycondone(post dose12-24h) 251.22  (198.78) 510.80  (462.41) 729.07  (343.84)
Noroxycodone(post dose0-2h) 23.29  (39.94) 63.80  (83.33) 157.75  (229.32)
Noroxycodone(post dose2-4h) 128.82  (117.04) 410.02  (283.62) 942.44  (529.85)
Noroxycodone(post dose4-8h) 282.31  (192.38) 828.97  (629.00) 1655.25  (736.42)
Noroxycodone(post dose8-12h) 421.75  (222.63) 1041.66  (699.41) 2015.62  (865.69)
Noroxycodone(post dose12-24h) 474.85  (232.06) 1170.41  (703.51) 2280.92  (936.47)
Hydroxymorphine(post dose0-2h) 0.51  (0.65) 0.94  (1.41) 2.89  (4.87)
Hydroxymorphine(post dose2-4h) 1.54  (1.56) 3.46  (3.79) 12.88  (10.40)
Hydroxymorphine(post dose4-8h) 3.27  (2.47) 9.27  (13.89) 18.73  (15.23)
Hydroxymorphine(post dose8-12h) 5.33  (4.83) 12.24  (16.33) 21.22  (15.56)
Hydroxymorphine(post dose12-24h) 7.64  (6.81) 13.91  (17.13) 24.11  (15.73)
Normethoxymorphone(post dose0-2h) 3.97  (6.96) 7.16  (11.48) 8.53  (13.63)
Normethoxymorphone(post dose2-4h) 19.40  (18.45) 30.68  (19.15) 48.82  (40.37)
Normethoxymorphone(post dose4-8h) 44.55  (44.62) 99.55  (143.15) 88.46  (53.96)
Normethoxymorphone(post dose8-12h) 73.14  (58.19) 129.72  (154.63) 136.84  (65.32)
Normethoxymorphone(post dose12-24h) 99.87  (76.02) 159.88  (184.11) 170.60  (74.03)
14.Primary Outcome
Title Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
Hide Description Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.
Time Frame post dose 24h
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Hydrochloride Single Dose 5 mg Oxycodone Hydrochloride Single Dose 10 mg Oxycodone Hydrochloride Single Dose 20 mg
Hide Arm/Group Description:
Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: % of ug
Oxycondone 5.02  (3.98) 5.11  (4.62) 3.65  (1.72)
Noroxycodone 9.50  (4.64) 11.70  (7.04) 11.40  (4.68)
Hydroxymorphine 0.15  (0.14) 0.14  (0.17) 0.12  (0.08)
Normethoxymorphone 2.00  (1.52) 1.60  (1.84) 0.85  (0.37)
15.Primary Outcome
Title The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
Hide Description The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.
Time Frame Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Hydrochloride Multiple Dose 10 mg
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Group 2: multiple dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: μg
Oxycondone(Pre-dose) 745.99  (1106.32)
Oxycondone(post dose0-2h) 263.32  (236.25)
Oxycondone(post dose2-4h) 342.64  (301.21)
Oxycondone(post dose4-8h) 431.70  (532.48)
Oxycondone(post dose8-12h) 137.13  (107.95)
Oxycondone(post dose12-24h) 344.15  (516.94)
Noroxycodone(Pre-dose) 897.44  (1121.80)
Noroxycodone(post dose0-2h) 372.51  (290.26)
Noroxycodone(post dose2-4h) 438.24  (218.90)
Noroxycodone(post dose4-8h) 515.39  (423.80)
Noroxycodone(post dose8-12h) 500.42  (717.43)
Noroxycodone(post dose12-24h) 865.37  (861.94)
Hydroxymorphine(Pre-dose) 9.43  (10.39)
Hydroxymorphine(post dose0-2h) 6.13  (8.11)
Hydroxymorphine(post dose2-4h) 24.03  (59.61)
Hydroxymorphine(post dose4-8h) 24.52  (27.45)
Hydroxymorphine(post dose8-12h) 15.10  (17.60)
Hydroxymorphine(post dose12-24h) 31.73  (36.65)
Normethoxymorphone(Pre-dose) 337.01  (460.24)
Normethoxymorphone(post dose0-2h) 130.63  (100.61)
Normethoxymorphone(post dose2-4h) 208.27  (183.64)
Normethoxymorphone(post dose4-8h) 262.56  (382.79)
Normethoxymorphone(post dose8-12h) 102.36  (91.74)
Normethoxymorphone(post dose12-24h) 240.75  (332.72)
16.Primary Outcome
Title Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
Hide Description Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .
Time Frame post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Hydrochloride Single Dose 10 mg
Hide Arm/Group Description:
Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: μg
Oxycondone(post dose0-2h) 263.32  (236.25)
Oxycondone(post dose2-4h) 605.96  (479.83)
Oxycondone(post dose4-8h) 1037.66  (985.45)
Oxycondone(post dose8-12h) 913.59  (374.77)
Oxycondone(post dose12-24h) 1290.63  (720.65)
Noroxycodone(post dose0-2h) 372.51  (290.26)
Noroxycodone(post dose2-4h) 810.75  (419.08)
Noroxycodone(post dose4-8h) 1326.14  (645.18)
Noroxycodone(post dose8-12h) 1693.83  (978.49)
Noroxycodone(post dose12-24h) 2618.44  (1237.37)
Hydroxymorphine(post dose0-2h) 6.13  (8.11)
Hydroxymorphine(post dose2-4h) 30.16  (64.24)
Hydroxymorphine(post dose4-8h) 54.68  (67.67)
Hydroxymorphine(post dose8-12h) 72.85  (72.84)
Hydroxymorphine(post dose12-24h) 108.81  (77.11)
Normethoxymorphone(post dose0-2h) 130.63  (100.61)
Normethoxymorphone(post dose2-4h) 338.90  (241.50)
Normethoxymorphone(post dose4-8h) 601.46  (566.37)
Normethoxymorphone(post dose8-12h) 575.47  (287.77)
Normethoxymorphone(post dose12-24h) 796.81  (518.90)
Time Frame Single dose group the screening period is maximal 7 days, then 1 day dosing and sampling following by 1 day safety follow up, so total 9 days maximal. Multiple dose group the screening period is maximal 7 days, then 4 days dosing and sampleing following by 1 day safety follow up, so total 12 days maximal.
Adverse Event Reporting Description No difference with the clinicaltrials.gov definition
 
Arm/Group Title Oxycodone Hydrochloride Single Dose(5mg) Oxycodone Hydrochloride Single Dose(10mg) Oxycodone Hydrochloride Single Dose(20mg) Oxycodone Hydrochloride Multiple Dose(10mg)
Hide Arm/Group Description Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
All-Cause Mortality
Oxycodone Hydrochloride Single Dose(5mg) Oxycodone Hydrochloride Single Dose(10mg) Oxycodone Hydrochloride Single Dose(20mg) Oxycodone Hydrochloride Multiple Dose(10mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Oxycodone Hydrochloride Single Dose(5mg) Oxycodone Hydrochloride Single Dose(10mg) Oxycodone Hydrochloride Single Dose(20mg) Oxycodone Hydrochloride Multiple Dose(10mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxycodone Hydrochloride Single Dose(5mg) Oxycodone Hydrochloride Single Dose(10mg) Oxycodone Hydrochloride Single Dose(20mg) Oxycodone Hydrochloride Multiple Dose(10mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/15 (53.33%)      11/15 (73.33%)      14/15 (93.33%)      12/16 (75.00%)    
Gastrointestinal disorders         
Nausea *  2/15 (13.33%)  2 5/15 (33.33%)  5 10/15 (66.67%)  10 4/16 (25.00%)  4
Vomiting *  2/15 (13.33%)  2 3/15 (20.00%)  3 7/15 (46.67%)  7 6/16 (37.50%)  7
Nervous system disorders         
Dizziness *  4/15 (26.67%)  4 10/15 (66.67%)  10 14/15 (93.33%)  14 4/16 (25.00%)  5
Drowsiness *  4/15 (26.67%)  4 3/15 (20.00%)  3 5/15 (33.33%)  6 0/16 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ms. Dan Zhu, Clinical operation and quality lead of the study
Organization: Mundipharma (China) Pharmaceutical Co.Ltd
Phone: +8610 6563 6891
EMail: dan.zhu@mundipharma.com.cn
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Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01643772    
Other Study ID Numbers: OXYC09-CN-102
First Submitted: November 17, 2011
First Posted: July 18, 2012
Results First Submitted: January 5, 2018
Results First Posted: October 21, 2019
Last Update Posted: October 21, 2019