To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Sandoz18 enrolled

Overview

To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Inflammation

Interventions

Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)DRUG

Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)DRUG

Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 32 days

Data from ClinicalTrials.gov

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