Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT01010139
• Lead Sponsor: Roxane Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to codeine sulfate or any comparable or similar product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	21 Days

Trial Locations

Locations (1)

CEDRA Clinical Research; 🇺🇸 San Antonio, Texas, United States