Clinical Trials Directory

Trials / Completed

CompletedNCT01010152

Comparative Bioavailability Study of Codeine Sulfate

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Roxane Laboratories · Industry
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

Conditions

Interventions

TypeNameDescription
DRUGCodeine Sulfate30 mg Tablet

Timeline

Start date
2008-01-01
Primary completion
2008-01-01
Completion
2008-01-01
First posted
2009-11-09
Last updated
2018-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01010152. Inclusion in this directory is not an endorsement.