NCT01009892CompletedPhase 1
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Codeine Sulfate Tablets Under Fasting and Fed Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Roxane Laboratories
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- bioequivalence determined by statistical comparison Cmax
Study Overview
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
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
Codeine Sulfate, 15 mg
Active Comparator
tablet
Intervention: Codeine Sulfate (Drug)
Codeine Sulfate, 60 mg
Active Comparator
tablet
Intervention: Codeine Sulfate (Drug)
Codeine Sulfate, 30 mg
Active Comparator
tablet
Intervention: Codeine Sulfate (Drug)
Outcomes
Primary Outcomes
bioequivalence determined by statistical comparison Cmax
Time Frame: 8 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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