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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PT Novell Pharmaceutical Laboratories
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Healthy subjects, both sexes, age between 18 to 55 years old

• Weight with normal range according to accepted normal values for BMI (18-25 kg/m2)

• Give a written informed consent

• Acceptable medical history and physical examination

• Normal hematology values including hemoglobin, hematocrit, WBC, platelets, WBC differential

• Normal laboratory test including : Blood urea nitrogen, sGPT, sGOT, alkaline phosphatase, total bilirubin, total protein, fasting glucose, albumin and creatinine

• Normal urinalysis results including: specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and casts

• Acceptable electrocardiogram (ECG) result

• Negative result for serological tests of Hepatitis B, Hepatitis C and HIV

• Negative result for pregnancy test

Exclusion Criteria:

• Smoker or alcoholism

• Pregnant woman or nursing mother

• Have history of hepatic, cardiovascular, gastrointestinal or renal disease

• Potentially sensitive to azithromycin or other related drugs

• Received any investigation drug within four weeks

• Donation or loss more than 450 mL of blood within 3 months prior to the screening