Fasting
Conditions
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
Interventions
DRUGAzithromycin
Single dose 500 mg of film coated tablet
Sponsors
PT Novell Pharmaceutical Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL) | 30 days |
Countries
Indonesia
Outcome results
None listed