NCT00882700

CompletedPhase 1

To Demonstrate the Relative Bioequivalence of Cefdinir and O...

Sandoz Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

50038

Study Type

interventional

Actual enrollment (reported)

28

Locations

0 countries

Sites

N/A

Timeline

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2005

Actual (reported)

Study Completion

April 2005

Actual (reported)

Brief Summary

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting 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): 28 participants
Study completion date: April 2005
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
April 2005
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2005
Actual (reported)
Study Completion
April 2005
Actual (reported)
First Submitted
April 15, 2009
Actual (reported)
First Posted
April 16, 2009
Actual (reported)

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

Conditions

Healthy

Keywords

Antibiotic

Outcome Measures

Primary Outcomes (1)

Bioequivalence based on AUC and Cmax
14 days

Study Arms (2)

1

EXPERIMENTAL

Cefdinir 300 mg Capsule (Sandoz, Austria)

Drug: Cefdinir 300 mg Capsule (Sandoz, Austria)

2

ACTIVE COMPARATOR

Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Drug: Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)

Interventions

Cefdinir 300 mg Capsule (Sandoz, Austria)Drug

1

Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, 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 - 56 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

Cefdinir

Intervention Hierarchy (Ancestors)

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

Study Officials

Richard Larouche, M.D.
SFBC Anapharm
PRINCIPAL INVESTIGATOR

Enrollment

28 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 15, 2009

First Posted

April 16, 2009

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

NCT00881153

To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.

Phase 1Completed

NCT00835484

Cefdinir Capsules 300 mg, Fasting

Phase 1Completed

NCT00881179

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

Phase 1Completed

NCT00834535

Cefdinir Capsules 300 mg, Non-fasting

Phase 1Completed

NCT00881400

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

Phase 1Completed

NCT00881855

To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed 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 2005

Actual (reported)

Study Completion

April 2005

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: NCT00882700
Data provider: ClinicalTrials.gov
Source updated: 2017-03-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:37 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