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Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions

NCT00601315 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-23

No results posted yet for this study

Summary

The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose, administered in the fasted state.

Conditions

Interventions

DRUG

Clarithromycin

Sponsors & Collaborators

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Mark J Allison, MD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2003-05-31
Completion
2003-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00601315 on ClinicalTrials.gov