NCT00881855

CompletedPhase 1

To Demonstrate the Relative Bioavailability of Cefzil 500 mg...

Sandoz Source

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Other study identifiers

Sponsor study identifier

AA17501

Study Type

interventional

Actual enrollment (reported)

35

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2004

Actual (reported)

Study Completion

April 2004

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 35 participants
Study completion date: April 2004
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2004
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2004
Actual (reported)
Study Completion
April 2004
Actual (reported)
First Submitted
April 14, 2009
Actual (reported)
First Posted
April 15, 2009
Actual (reported)

Last Updated: March 29, 2017
Status Verified: April 2009
Last Update Submitted: March 27, 2017

Conditions

Healthy

Keywords

Antibiotics

Outcome Measures

Primary Outcomes (1)

Bioequivalence based on AUC and Cmax
15 days

Study Arms (2)

1

EXPERIMENTAL

Cefprozil 500 mg Tablets (Sandoz, GmbH)

Drug: Cefprozil 500 mg Tablets (Sandoz, GmbH)

2

ACTIVE COMPARATOR

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

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

Interventions

Cefprozil 500 mg Tablets (Sandoz, GmbH)Drug

1

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

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

You may not qualify if:

Sponsors & Collaborators

Sandoz
Industrylead

MeSH Terms

Interventions

Cefprozil

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Gaetano Morelli, M.D.
MDS Pharma Services
PRINCIPAL INVESTIGATOR

Enrollment

35 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

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Phase 1Completed

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Phase 1Completed

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To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

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NCT00882154

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

Phase 1Completed

NCT00883883

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions

Phase 1Completed

NCT00882700

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

Phase 1Completed

Positive test results for HIV or hepatitis B or C.

Treatment for drug or alcohol dependence.

Contact the study team to confirm eligibility.

Primary Completion

April 2004

Actual (reported)

Study Completion

April 2004

Actual (reported)

Last Updated

March 29, 2017

Record last verified: 2009-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00881855
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:51 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record