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Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

NCT00648830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-04-24

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 250 mg (1 x 250 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this four-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 250 mg tablets are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered under fasted conditions.

Conditions

  • Healthy

Interventions

PROCEDURE

Clarithromycin

Single-dose of Clarithromycin 250 mg oral immediate-release tablets

DRUG

Clarithromycin

single-dose 250 mg immediate-release oral tablets

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2004-06-30
Completion
2004-06-30

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 NCT00648830 on ClinicalTrials.gov