NCT01602055

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PT Novell Pharmaceutical Laboratories · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Azithromycin	Single dose 500 mg of film coated tablet
DRUG	Azithromycin	Single dose 500 mg of film coated tablet

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2012-05-18
• Last updated: 2012-05-21

Locations

1 site across 1 country: Indonesia