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

Phase 1

Completed

• Conditions: Fasting
• Interventions: Drug: Azithromycin

• Registration Number: NCT01602055
• Lead Sponsor: PT Novell Pharmaceutical Laboratories

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-16
• Last Update Submitted: 2012-05-17
• Study First Posted: 2012-05-18
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zithromax	Azithromycin	-
Azivol	Azithromycin	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL)	30 days

Trial Locations

Locations (1)

PT Clinisindo Laboratories; 🇮🇩 Jakarta, Indonesia