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

Charleston Laboratories, Inc20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CL-108DRUG

Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth

VicoprofenDRUG

Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth

UltracetDRUG

Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data

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.