CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
CL-108 +3 moredrug
Likely dose
CL-108 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02465866
NCT02465866Phase 1Completed
CompareCT.gov

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

Charleston Laboratories, Inc·interventional·Posted Jun 9, 2015·Updated May 2, 2017

In Brief

A Phase 1 clinical trial evaluating CL-108, Vicoprofen, and 2 other interventions for Healthy. Completed, enrolled 20 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 9, 2015
Enrollment StartNov 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.1 years ago

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

Phenergandrug

Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth