To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Phase 1
Completed
- Conditions
- Inflammation
- Interventions
- Registration Number
- NCT00914160
- Lead Sponsor
- Sandoz
- Brief Summary
To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets under non-fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc) Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc) 2 Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc) Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc) 3 Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
- Primary Outcome Measures
Name Time Method Bioequivalence based on AUC and Cmax 31 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 molecular mechanisms underlie diclofenac sodium's anti-inflammatory effects in Phase 1 trials?
How does the bioavailability of diclofenac sodium compare to Voltaren in non-fasting conditions for inflammation management?
Are there specific biomarkers that correlate with enhanced diclofenac sodium efficacy in enteric-coated formulations for inflammatory conditions?
What adverse events are associated with diclofenac sodium 50 mg enteric-coated tablets in non-fasting Phase 1 studies, and how are they managed?
How do diclofenac sodium formulations from Geneva Pharmaceuticals and Geigy Pharmaceuticals compare in terms of therapeutic outcomes for inflammation?