Clinical trial NCT02465866: A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Official title: A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Plasma concentration
Time to plasma concentration
Elimination rate constant
Elimination half life
Area under the curve
Lead sponsor: Charleston Laboratories, Inc
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data
timeFrame: 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
measure: Time to Reach Maximum Concentration (Tmax)
timeFrame: 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
measure: Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data
timeFrame: 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
measure: Time of the Last Quantifiable Concentration (Tlast)
timeFrame: 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
measure: Observed Elimination Rate Constant (λz)
timeFrame: 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
measure: Observed Terminal Elimination Half-life (T1/2)
timeFrame: 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
measure: Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine
timeFrame: 0 (pre-dose) to 0.25 hours post-dose
measure: AUC0-0.50 for Hydrocodone and Promethazine
timeFrame: 0 (pre-dose) to 0.5 hours post-dose
measure: AUC0-0.75 for Hydrocodone and Promethazine
timeFrame: 0 (Pre-dose) to 0.75 hours post-dose
measure: AUC0-1.0 for Hydrocodone and Promethazine
timeFrame: 0 (pre-dose) to 1.0 hours post-dose
measure: AUC0-1.5 for Hydrocodone and Promethazine
timeFrame: 0 (pre-dose) to 1.5 hours post-dose
measure: AUC0-2.0 for Hydrocodone and Promethazine
timeFrame: 0 (pre-dose) to 2 hours post-dose
measure: AUC0-4.0 for Hydrocodone and Promethazine
timeFrame: 0 (pre-dose) to 4 hours post-dose
measure: Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration
timeFrame: 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
measure: Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity
timeFrame: 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
measure: Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: