Steady State Study of Codeine Sulfate
Phase 1
Completed
- Conditions
- Pain
- Registration Number
- NCT01009853
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.
- 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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 6 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CEDRA Clinical Research
🇺🇸Austin, Texas, United States