To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cefprozil 500 mg Tablets (Sandoz GmbH); Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881426

AA17499

Details and patient eligibility

About

To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting conditions.

Enrollment: 26 patients

Sex: All

Ages: 20 to 54 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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26 participants in 2 patient groups

1

Experimental group

Description:

Cefprozil 500 mg Tablets (Sandoz GmbH)

Treatment:

Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)

2

Active Comparator group

Description:

Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)

Treatment:

Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)