NCT00913887CompletedPhase 1
A Relative Bioavailability Study of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 18
- Primary Endpoint
- Bioequivalence based on AUC and Cmax
Study Overview
Brief Summary
To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
1
Experimental
Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
Intervention: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical) (Drug)
2
Experimental
Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
Intervention: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical) (Drug)
3
Active Comparator
Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
Intervention: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) (Drug)
Outcomes
Primary Outcomes
Bioequivalence based on AUC and Cmax
Time Frame: 32 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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