Food Effect Study of 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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the impact of food on codeine sulfate pharmacokinetics in pain management?
How does codeine sulfate compare to other opioid analgesics in phase 1 bioequivalence studies?
Are there specific CYP2D6 polymorphisms that affect codeine sulfate metabolism under fasting or fed conditions?
What adverse events are associated with codeine sulfate absorption in fed versus fasting states?
How does the bioavailability of codeine sulfate tablets from Roxane Laboratories correlate with pain relief efficacy in clinical settings?
Trial Locations
- Locations (1)
CEDRA Clinical Research
🇺🇸San Antonio, Texas, United States
CEDRA Clinical Research🇺🇸San Antonio, Texas, United States