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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Inflammation

Treatments: Drug: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical); Drug: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals); Drug: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913887

B-04124

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Male

Ages: 18 to 40 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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18 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Experimental group

Description:

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

Treatment:

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

3

Active Comparator group

Description:

Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

Treatment:

Drug: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)