NCT01010152CompletedPhase 1
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Comparative Bioavailability Study fo Codeine 30 mg Tablets and Tylenol #3 Tablets Under Fasting Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Roxane Laboratories
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- bioequivalence determined by statistical comparison Cmax
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Tylenol #3
Active Comparator
30 mg tablet
Intervention: Codeine Sulfate (Drug)
Codeine Sulfate
Experimental
30 mg tablet
Intervention: Codeine Sulfate (Drug)
Outcomes
Primary Outcomes
bioequivalence determined by statistical comparison Cmax
Time Frame: 15 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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