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

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fed Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881400

Enrollment

Registered

2009-04-15

Start date

2004-06-30

Completion date

2004-06-30

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Antibiotic

Brief summary

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

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	15 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026