To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets

Sandoz

Status and phase: Completed; Phase 1

Conditions: Inflammation

Treatments: Drug: Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc); Drug: Voltaren 50 mg Tablets (Geigy Pharmaceuticals)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913224

B-03113

Details and patient eligibility

About

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.

Enrollment: 38 patients

Sex: Male

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Description:

Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)

Treatment:

Drug: Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)

2

Active Comparator group

Description:

Voltaren 50 mg Tablets (Geigy Pharmaceuticals)

Treatment:

Drug: Voltaren 50 mg Tablets (Geigy Pharmaceuticals)