NCT01009853

Steady State Study of Codeine Sulfate

A Single Dose, 1-Period, 1-Treatment Study of Codeine Sulfate 15 mg Tablets Under Steady State 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

Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Codeine Sulfate	15 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