Comparative Bioavailability Study of Codeine Sulfate
- Registration Number
- NCT01010152
- Lead Sponsor
- Roxane Laboratories
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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 Tylenol #3 Codeine Sulfate 30 mg tablet Codeine Sulfate Codeine Sulfate 30 mg tablet
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 15 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CEDRA Clinical Research LLC
🇺🇸San Antonio, Texas, United States
CEDRA Clinical Research LLC🇺🇸San Antonio, Texas, United States