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

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefprozil 500 mg Tablets (Sandoz GmbH)

Drug

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

Drug

Primary outcomes

Bioequivalence based on AUC and Cmax

Time frame: 16 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fasting Conditions

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Apr 15, 2009
Registry last updated: Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed