To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA); Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881400

AA17503

Details and patient eligibility

About

To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension fed conditions.

Enrollment: 24 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)

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24 participants in 2 patient groups

1

Experimental group

Description:

Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)

Treatment:

Drug: Cefprozil 250 mg/5 ml Oral Suspension (Sandoz, Austria)

2

Active Comparator group

Description:

Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)

Treatment:

Drug: Cefzil (Cefprozil) 250 mg/5 ml Oral Suspension (Bristol-Myers Squibb, USA)