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

PT Novell Pharmaceutical Laboratories

Status and phase

Completed

Phase 1

Conditions

Fasting

Treatments

Drug: Azithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01602055

XXI/32/CL/2009

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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