NCT02465866

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Charleston Laboratories, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CL-108	Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
DRUG	Vicoprofen	Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
DRUG	Ultracet	Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
DRUG	Phenergan	Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-06-09
• Last updated: 2017-05-02
• Results posted: 2017-03-20