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A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

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ClinicalTrials.gov Identifier: NCT02465866
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : March 20, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Hazelton, Charleston Laboratories, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: CL-108
Drug: Vicoprofen
Drug: Ultracet
Drug: Phenergan
Enrollment 20
Recruitment Details Twenty healthy subjects were enrolled in the study.
Pre-assignment Details  
Arm/Group Title Sequence 1: ABDC Sequence 2: BCAD Sequence 3: CDBA Sequence 4: DACB
Hide Arm/Group Description

Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition

Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition

Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition

Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition

Dosing in 4 study periods was separated by a 14-day washout period

Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition

Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition

Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition

Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition

Dosing in 4 study periods was separated by a 14-day washout period

Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition

Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition

Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition

Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition

Dosing in 4 study periods was separated by a 14-day washout period

Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition

Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition

Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition

Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition

Dosing in 4 study periods was separated by a 14-day washout period

Period Title: Period 1
Started 5 5 5 5
Completed 5 5 5 5
Not Completed 0 0 0 0
Period Title: Period 1: Washout (14 Days)
Started 5 5 5 5
Completed 5 5 5 5
Not Completed 0 0 0 0
Period Title: Period 2
Started 5 5 5 5
Completed 5 5 5 5
Not Completed 0 0 0 0
Period Title: Period 2: Washout (14 Days)
Started 5 5 5 5
Completed 5 5 5 5
Not Completed 0 0 0 0
Period Title: Period 3
Started 5 5 5 5
Completed 5 4 5 5
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Period Title: Period 3: Washout (14 Days)
Started 5 4 5 5
Completed 5 4 5 5
Not Completed 0 0 0 0
Period Title: Period 4
Started 5 4 5 5
Completed 5 4 5 5
Not Completed 0 0 0 0
Period Title: Period 4: Washout (14 Days)
Started 5 4 5 5
Completed 5 4 5 5
Not Completed 0 0 0 0
Arm/Group Title Overall Subjects
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
52.85  (17.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
14
  70.0%
Male
6
  30.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
11
  55.0%
Not Hispanic or Latino
9
  45.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
1
   5.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  10.0%
White
17
  85.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
1
   5.0%
Black or African American
2
  10.0%
White
17
  85.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 20 participants
163.15  (10.49)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 20 participants
67.83  (10.72)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 20 participants
25.43  (2.80)
1.Primary Outcome
Title Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
Hide Description Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intended to treat (ITT) population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Hydrocodone 20.0  (5.48) 17.9  (5.80) 18.4  (5.62) 17.5  (3.63)
Acetaminophen 4.71  (1.49) 3.27  (1.00) 5.02  (1.66) 3.03  (0.919)
Promethazine (Number of Participants=19,19,20,19) 4.79  (3.75) 3.66  (2.16) 4.35  (2.94) 4.08  (1.95)
2.Primary Outcome
Title Time to Reach Maximum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: hours
Hydrocodone 1.55  (0.71) 3.38  (1.58) 1.39  (1.22) 3.09  (1.89)
Acetaminophen 0.91  (0.44) 2.84  (1.49) 0.80  (0.55) 2.64  (1.44)
Promethazine (Number of Participants=19,19,20,19) 4.35  (1.37) 5.24  (2.37) 4.90  (1.72) 6.45  (4.59)
3.Primary Outcome
Title Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Hydrocodone 0.556  (0.354) 0.523  (0.412) 0.465  (0.315) 0.527  (0.424)
Acetaminophen 0.0741  (0.0297) 0.0917  (0.0378) 0.0724  (0.0291) 0.0907  (0.0428)
Promethazine (Number of Participants=19,19,20,19) 0.611  (0.936) 0.586  (1.04) 0.574  (0.829) 0.701  (0.912)
4.Primary Outcome
Title Time of the Last Quantifiable Concentration (Tlast)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: Hours
Hydrocodone 27.80  (8.99) 31.21  (11.28) 28.81  (9.84) 31.58  (11.46)
Acetaminophen 23.38  (2.76) 24.01  (0.04) 23.41  (2.69) 24.01  (0.02)
Promethazine (Number of Participants=19,19,20,19) 46.76  (5.51) 46.77  (5.52) 46.81  (5.37) 46.74  (5.51)
5.Primary Outcome
Title Observed Elimination Rate Constant (λz)
Hide Description Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h-1
Hydrocodone 0.1468  (0.0293) 0.1373  (0.0258) 0.1415  (0.0292) 0.1371  (0.0271)
Acetaminophen 0.1577  (0.0310) 0.1359  (0.0223) 0.1600  (0.0355) 0.1412  (0.0218)
Promethazine (Number of Participants=19,18,20,18) 0.0429  (0.0129) 0.0451  (0.0451) 0.0422  (0.0120) 0.0458  (0.0145)
6.Primary Outcome
Title Observed Terminal Elimination Half-life (T1/2)
Hide Description Calculated as: T1/2 = ln(2)/λz
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: hours
Hydrocodone 4.93  (1.11) 5.22  (0.99) 5.13  (1.18) 5.26  (1.08)
Acetaminophen 4.59  (1.06) 5.22  (0.79) 4.52  (0.93) 5.03  (0.86)
Promethazine (Number of Participants=19,18,20,18) 17.49  (5.21) 15.95  (3.04) 17.77  (5.57) 16.24  (4.09)
7.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine
Hide Description AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (pre-dose) to 0.25 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 0.08870  (0.1318) 0.03786  (0.1269) 0.1219  (0.2151) 0.02250  (0.04577)
Promethazine (Number of Participants=19,19,20,19) 0.01086  (0.03169) 0.003941  (0.01413) 0.006288  (0.02608) 0.002612  (0.01138)
8.Primary Outcome
Title AUC0-0.50 for Hydrocodone and Promethazine
Hide Description AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (pre-dose) to 0.5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 0.9532  (0.9498) 0.2566  (0.6382) 1.280  (1.271) 0.3163  (0.4305)
Promethazine (Number of Participants=19,19,20,19) 0.03535  (0.06239) 0.01570  (0.03508) 0.02692  (0.06096) 0.01220  (0.02452)
9.Primary Outcome
Title AUC0-0.75 for Hydrocodone and Promethazine
Hide Description AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (Pre-dose) to 0.75 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 3.194  (2.379) 0.8759  (1.645) 4.027  (3.092) 1.276  (1.629)
Promethazine (Number of Participants=19,19,20,19) 0.1108  (0.1090) 0.05549  (0.08128) 0.09690  (0.1478) 0.04610  (0.06227)
10.Primary Outcome
Title AUC0-1.0 for Hydrocodone and Promethazine
Hide Description AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (pre-dose) to 1.0 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 6.383  (3.637) 2.046  (3.244) 7.524  (4.678) 2.722  (3.329)
Promethazine (Number of Participants=19,19,20,19) 0.2578  (0.1999) 0.1457  (0.1649) 0.2311  (0.3055) 0.1109  (0.1471)
11.Primary Outcome
Title AUC0-1.5 for Hydrocodone and Promethazine
Hide Description AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (pre-dose) to 1.5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 14.33  (4.971) 5.782  (7.049) 14.95  (6.822) 6.424  (6.742)
Promethazine (Number of Participants=19,19,20,19) 0.8524  (0.5410) 0.5573  (0.4798) 0.7330  (0.8395) 0.3239  (0.3643)
12.Primary Outcome
Title AUC0-2.0 for Hydrocodone and Promethazine
Hide Description AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (pre-dose) to 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 23.21  (6.240) 10.95  (10.34) 22.53  (8.183) 11.04  (10.12)
Promethazine (Number of Participants=19,19,20,19) 1.938  (1.318) 1.267  (0.9936) 1.583  (1.689) 0.6735  (0.6328)
13.Primary Outcome
Title AUC0-4.0 for Hydrocodone and Promethazine
Hide Description AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.
Time Frame 0 (pre-dose) to 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 54.04  (13.77) 38.97  (18.47) 48.35  (12.87) 35.14  (17.97)
Promethazine (Number of Participants=19,19,20,19) 9.124  (6.271) 5.943  (3.676) 7.101  (6.159) 4.045  (2.497)
14.Primary Outcome
Title Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration
Hide Description Calculated using the linear trapezoidal rule
Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
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Hide Analysis Population Description
ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
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CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 146.2  (56.77) 151.9  (58.79) 130.9  (47.94) 148.5  (56.84)
Acetaminophen 19.19  (5.661) 17.85  (4.621) 18.69  (5.186) 17.85  (4.742)
Promethazine (Number of Participants=19,19,20,19) 75.69  (78.87) 66.63  (67.37) 68.54  (63.24) 74.76  (57.53)
15.Primary Outcome
Title Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity
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Calculated as:

AUCinf = AUClast + Clast/λz

Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
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ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Hydrocodone 150.2  (57.30) 155.8  (58.75) 134.3  (48.20) 152.4  (56.83)
Promethazine (Number of Participants=19,18,20,18) 96.92  (119.5) 60.72  (29.74) 88.53  (100.3) 84.13  (76.72)
16.Primary Outcome
Title Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation
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Calculated as:

AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100

Time Frame 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose
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ITT population
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description:
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
Overall Number of Participants Analyzed 19 20 20 19
Mean (Standard Deviation)
Unit of Measure: Percentage of AUCExtrap
Hydrocodone 2.72  (1.72) 2.68  (1.97) 2.65  (1.78) 2.71  (2.06)
Promethazine (Number of Participants=19,18,20,18) 14.35  (7.03) 13.54  (4.64) 15.15  (7.86) 14.56  (6.28)
Time Frame Up to day 72
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Hide Arm/Group Description CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
All-Cause Mortality
Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A: CL-108 (Fasted) Treatment B: CL-108 (Fed) Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/19 (15.79%)   11/20 (55.00%)   20/20 (100.00%)   2/19 (10.53%) 
Gastrointestinal disorders         
Diarrhoea  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/19 (0.00%) 
Dry mouth  1  1/19 (5.26%)  0/20 (0.00%)  0/20 (0.00%)  0/19 (0.00%) 
Glossodynia  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%) 
Nausea  1  1/19 (5.26%)  2/20 (10.00%)  4/20 (20.00%)  0/19 (0.00%) 
Oral pruritus  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%) 
Vomiting  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%) 
General disorders         
Vessel puncture site pain  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%) 
Nervous system disorders         
Dizziness  1  1/19 (5.26%)  1/20 (5.00%)  3/20 (15.00%)  0/19 (0.00%) 
Headache  1  0/19 (0.00%)  2/20 (10.00%)  1/20 (5.00%)  0/19 (0.00%) 
Somnolence  1  0/19 (0.00%)  1/20 (5.00%)  2/20 (10.00%)  2/19 (10.53%) 
Psychiatric disorders         
Euphoric mood  1  0/19 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/19 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/19 (0.00%) 
Vascular disorders         
Hot flush  1  0/19 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/19 (0.00%) 
Hypotension  1  0/19 (0.00%)  2/20 (10.00%)  3/20 (15.00%)  0/19 (0.00%) 
Orthostatic hypotension  1  0/19 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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
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Name/Title: Chief Commercial Officer
Organization: Charleston Laboratories, Inc
Phone: 561-748-2007
EMail: cliregulatory@charlestonlabs.com
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Responsible Party: Joseph Hazelton, Charleston Laboratories, Inc
ClinicalTrials.gov Identifier: NCT02465866     History of Changes
Other Study ID Numbers: CLCT-004
First Submitted: June 4, 2015
First Posted: June 9, 2015
Results First Submitted: November 14, 2016
Results First Posted: March 20, 2017
Last Update Posted: May 2, 2017