Food Effect Study of Codeine Sulfate

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Codeine Sulfate

• Registration Number: NCT01009892
• Lead Sponsor: Roxane Laboratories

Brief Summary

The study was designed to assess the effect of food on the absorption of codeine from Roxane Laboratories' 60 mg Codeine Sulfate tablet

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• 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: 36

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

Arm && Interventions

Group	Intervention	Description
Codeine Sulfate, 15 mg	Codeine Sulfate	tablet
Codeine Sulfate, 30 mg	Codeine Sulfate	tablet
Codeine Sulfate, 60 mg	Codeine Sulfate	tablet

Primary Outcome Measures

Name	Time	Method
bioequivalence determined by statistical comparison Cmax	8 days

Trial Locations

Locations (1)

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