To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed 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, USA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881855

AA17501

Details and patient eligibility

About

The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 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)

---

35 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, USA)

Treatment:

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