A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02465866
- Lead Sponsor
- Charleston Laboratories, Inc
- Brief Summary
This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Written informed consent
- Subject's body mass index (BMI) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb)
- Abide by study restrictions
- Acceptable birth control measures
- Ability to attend all study visits
- Vital signs as per protocol
- Willing to consume high calorie meals within designated time frame
- Clinically significant medical history
- Clinically significant abnormal findings
- History or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (NSAIDs), promethazine, or related drugs.
- Has smoked or used tobacco products within 60 days prior to the first dose of study medication
- Has donated blood or plasma within 30 days prior to the first dose of study medication
- Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Phenergan 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, Ultracet and Phenergan (Fed) Phenergan 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, Ultracet and Phenergan (Fasted) Ultracet 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, Ultracet and Phenergan (Fed) Vicoprofen 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 (Fasted) CL-108 CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition Treatment D: Vicoprofen, Ultracet and Phenergan (Fed) Ultracet 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 (Fed) CL-108 CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted) Vicoprofen Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
- Primary Outcome Measures
Name Time Method Time of the Last Quantifiable Concentration (Tlast) 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 AUC0-2.0 for Hydrocodone and Promethazine 0 (pre-dose) to 2 hours post-dose AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.
Observed Elimination Rate Constant (λz) 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 Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile
AUC0-0.75 for Hydrocodone and Promethazine 0 (Pre-dose) to 0.75 hours post-dose AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.
Time to Reach Maximum Concentration (Tmax) 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 Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data 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 Observed Terminal Elimination Half-life (T1/2) 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 Calculated as: T1/2 = ln(2)/λz
Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data 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 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.
AUC0-0.50 for Hydrocodone and Promethazine 0 (pre-dose) to 0.5 hours post-dose AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-1.0 for Hydrocodone and Promethazine 0 (pre-dose) to 1.0 hours post-dose AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-1.5 for Hydrocodone and Promethazine 0 (pre-dose) to 1.5 hours post-dose AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.
Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine 0 (pre-dose) to 0.25 hours post-dose AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.
AUC0-4.0 for Hydrocodone and Promethazine 0 (pre-dose) to 4 hours post-dose AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.
Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration 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 Calculated using the linear trapezoidal rule
Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation 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 Calculated as:
AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf \*100Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity 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 Calculated as:
AUCinf = AUClast + Clast/λz
- Secondary Outcome Measures
Name Time Method