NCT01010139

Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Roxane Laboratories · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Codeine Sulfate	15 mg, 30 mg and 60 mg Tablet

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2009-11-09
• Last updated: 2018-01-23

Locations

1 site across 1 country: United States