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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Azivol

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Single dose 500 mg of film coated tablet

Zithromax

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Single dose 500 mg of film coated tablet

Interventions

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Azithromycin

Single dose 500 mg of film coated tablet

Intervention Type DRUG

Azithromycin

Single dose 500 mg of film coated tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes