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

Condition(s) targeted: Healthy

Intervention: CL-108 (Fasted) (Drug); CL-108 (Fed) (Drug); Vicoprofen, Ultracet and Phenegran (Fasted) (Drug); Vicoprofen, Ultracet and Phenegran (Fed) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Charleston Laboratories, Inc

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.

Official title: A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Plasma pharmacokinetics to assess relative bioavailability of CL-108 to comparator in the fed and fasted state

Pharmacokinetic plasma concentration

Pharmacokinetic parameter, time to plasma concentration

Pharmacokinetic parameter, elimination rate constant

Pharmacokinetic parameter, elimination half life

Pharmacokinetic parameter, area under the curve

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: November 2014
Last updated: June 4, 2015