NCT00914160CompletedPhase 1
A Relative Bioavailability Study of Diclofenac Sodium 50 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 50 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 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)
Intervention: Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc) (Drug)
2
Experimental
Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)
Intervention: Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc) (Drug)
3
Active Comparator
Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)
Intervention: Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) (Drug)
Outcomes
Primary Outcomes
Bioequivalence based on AUC and Cmax
Time Frame: 31 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Phase 1
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated TabletsInflammationNCT00913224Sandoz38
Completed
Phase 1
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting ConditionsInflammationNCT00913887Sandoz18
Completed
Phase 1
Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy VolunteersHealthyNCT03074162Boehringer Ingelheim48
Completed
Early Phase 1
Evaluation of Bioavailability of Diclofenac Dermal ProductsBioavailabilityNCT03145259University of Maryland, Baltimore12
Completed
Phase 1
Relative Bioavailability of Ibuprofen From a Single Fixed Dose Combination Tablet of Ibuprofen and Caffeine Compared to Single Tablets of Ibuprofen and Ibuprofen LysinateHealthyNCT01879371Boehringer Ingelheim36