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Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT00759902
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : September 1, 2009
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Actavis Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: morphine sulfate extended-release capsules
Drug: KADIAN (morphine sulfate extended-release) capsules
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Period 1: Treatment A or B Period 2: Treatment A or B
Hide Arm/Group Description Treatment A (test product) followed by Treatment B (reference product) Treatment B (reference product) followed by Treatment A (test product)
Period Title: Overall Study
Started 18 18
Completed 18 17
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Period 1: Treatment A or B Period 2: Treatment A or B Total
Hide Arm/Group Description Treatment A (test product) followed by Treatment B (reference product) Treatment B (reference product) followed by Treatment A (test product) Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
18
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
31.6  (9.6) 31.7  (8.9) 31.7  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
10
  55.6%
10
  55.6%
20
  55.6%
Male
8
  44.4%
8
  44.4%
16
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 36 participants
18 18 36
1.Primary Outcome
Title Maximum Plasma Morphine Concentration
Hide Description [Not Specified]
Time Frame 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KADIAN 10 mg Capsules KADIAN 20 mg Capsules
Hide Arm/Group Description:
2 x 10 mg KADIAN capsules
1 x 20 mg KADIAN capsules
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.23  (2.01) 4.15  (1.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KADIAN 10 mg Capsules, KADIAN 20 mg Capsules
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments log-transformation
Method of Estimation Estimation Parameter mean ratio
Estimated Value 123.0
Confidence Interval 90%
112.9 to 134.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time of Maximum Plasma Morphine Concentration
Hide Description [Not Specified]
Time Frame 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KADIAN 10 mg Capsules KADIAN 20 mg Capsules
Hide Arm/Group Description:
2 x 10 mg KADIAN capsules
1 x 20 mg KADIAN capsules
Overall Number of Participants Analyzed 35 35
Median (Full Range)
Unit of Measure: hr
7.50
(6.00 to 12.00)
7.50
(6.00 to 18.00)
3.Secondary Outcome
Title Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
Hide Description [Not Specified]
Time Frame 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KADIAN 10 mg Capsules KADIAN 20 mg Capsules
Hide Arm/Group Description:
2 x 10 mg KADIAN capsules
1 x 20 mg KADIAN capsules
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
84.45  (22.29) 82.94  (21.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KADIAN 10 mg Capsules, KADIAN 20 mg Capsules
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments log-transformation
Method of Estimation Estimation Parameter mean ratio
Estimated Value 101.7
Confidence Interval 90%
98.5 to 104.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Area Under the Curve to Infinity for Plasma Morphine
Hide Description [Not Specified]
Time Frame 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KADIAN 10 mg Capsules KADIAN 20 mg Capsules
Hide Arm/Group Description:
2 x 10 mg KADIAN capsules
1 x 20 mg KADIAN capsules
Overall Number of Participants Analyzed 31 33
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
102.1  (31.63) 100.0  (28.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KADIAN 10 mg Capsules, KADIAN 20 mg Capsules
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments log-transformation
Method of Estimation Estimation Parameter mean ratio
Estimated Value 102.9
Confidence Interval 90%
99.3 to 106.5
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Treatment A Followed by Treatment B Arm 2: Treatment B Followed by Treatment A
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Arm 1: Treatment A Followed by Treatment B Arm 2: Treatment B Followed by Treatment A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm 1: Treatment A Followed by Treatment B Arm 2: Treatment B Followed by Treatment A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Treatment A Followed by Treatment B Arm 2: Treatment B Followed by Treatment A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10      10    
Cardiac disorders     
Chest Pain  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Palpitations  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  4/18 (22.22%)  4 3/18 (16.67%)  3
Bowel  1  1/18 (5.56%)  1 1/18 (5.56%)  1
Constipation  1  2/18 (11.11%)  2 0/18 (0.00%)  0
Flatulence  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Abdominal Pain  1  1/18 (5.56%)  1 2/18 (11.11%)  2
Vomiting  1  0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders     
Hunger  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations     
Genital Herpes  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders     
Headache  1  3/18 (16.67%)  3 6/18 (33.33%)  6
Dizziness  1  1/18 (5.56%)  1 1/18 (5.56%)  1
Paraesthesia  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Psychiatric disorders     
Abnormal Dreams  1  0/18 (0.00%)  0 1/18 (5.56%)  2
Reproductive system and breast disorders     
Dysmenorrhea  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders     
Pruritis  1  1/18 (5.56%)  1 0/18 (0.00%)  0
Skin Laceration  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Skin Burning Sensation  1  0/18 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Meena Venugopal, Director, Clinical R&D
Organization: Actavis Inc.
Phone: 908-659-2885
EMail: MVenugopal@actavis.com
Layout table for additonal information
Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00759902    
Other Study ID Numbers: 20-073-SA
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: December 5, 2008
Results First Posted: September 1, 2009
Last Update Posted: August 17, 2010