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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charleston Laboratories, Inc
• Treatments: Diphenhydramine; Promethazine

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.