NCT00881738

CompletedPhase 1

To Demonstrate the Relative Bioavailability of Clarithromyci...

Sandoz Source

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Other study identifiers

Sponsor study identifier

B013720

Study Type

interventional

Actual enrollment (reported)

32

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2002

Actual (reported)

Study Completion

July 2002

Actual (reported)

Brief Summary

To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under 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): 32 participants
Study completion date: July 2002
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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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
June 2002
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2002
Actual (reported)
Study Completion
July 2002
Actual (reported)
First Submitted
April 13, 2009
Actual (reported)
First Posted
April 15, 2009
Actual (reported)

Last Updated: March 28, 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
9 days

Study Arms (2)

1

EXPERIMENTAL

Clarithromycin 250 mg Tablets (Geneva, USA)

Drug: Clarithromycin 250 mg Tablets (Geneva, USA)

2

ACTIVE COMPARATOR

Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)

Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)

Interventions

Clarithromycin 250 mg Tablets (Geneva, USA)Drug

1

Biaxin 250 mg Tablets (Abbott Laboratories, Inc, 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

Age19 Years - 54 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

Clarithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

So Ran Hong, M.D.
Novum Pharmaceutical Research Services
PRINCIPAL INVESTIGATOR

Enrollment

32 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 13, 2009

First Posted

April 15, 2009

Study Start

June 2002

Date type not reported

This date has not been verified as actual or estimated.

NCT00881855

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

Phase 1Completed

NCT00883155

To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions

Phase 1Completed

NCT00836706

Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

Phase 1Completed

NCT00774189

Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions

Phase 1Completed

NCT00835692

Clarithromycin 500 mg Tablets Under Fasting Conditions

Phase 1Completed

NCT00883883

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

June 2002

Actual (reported)

Study Completion

July 2002

Actual (reported)

Last Updated

March 28, 2017

Record last verified: 2009-04

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00881738
Data provider: ClinicalTrials.gov
Source updated: 2017-03-28
Normalization version: ctgov-legacy-1

Open registry record

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