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

NCT ID: NCT00881426

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cefprozil 500 mg Tablets (Sandoz GmbH)

Group Type EXPERIMENTAL

Cefprozil 500 mg Tablets (Sandoz GmbH)

Intervention Type DRUG

2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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Cefprozil 500 mg Tablets (Sandoz GmbH)

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz Inc.

Principal Investigators

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Gaetano Morelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Other Identifiers

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AA17499

Identifier Type: -

Identifier Source: org_study_id

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