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Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State

NCT00648960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2008-04-01

No results posted yet for this study

Summary

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Clarithromycin

Single-dose 500 mg immediate-release oral tablet

DRUG

Clarithromycin

Single-dose 500 mg immediate-release oral dose

Sponsors & Collaborators

  • Genpharm ULC

    collaborator INDUSTRY

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, M.D. · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2003-07-31
Completion
2003-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648960 on ClinicalTrials.gov