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A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects

NCT01602055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-05-21

No results posted yet for this study

Summary

The aim of this study is to assess the bioequivalence of 500 mg Azithromycin FC tablets (Azivol) produced by PT. Novell Pharmaceutical Laboratories, compared to the reference product Zithromax 500 mg FC tablet produced by Pfizer Australia Pty, Ltd

Conditions

  • Fasting

Interventions

DRUG

Azithromycin

Single dose 500 mg of film coated tablet

DRUG

Azithromycin

Single dose 500 mg of film coated tablet

Sponsors & Collaborators

  • PT Novell Pharmaceutical Laboratories

    lead INDUSTRY

Principal Investigators

  • Yahdiana Harahap, Prof · Indonesia University

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

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 NCT01602055 on ClinicalTrials.gov