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NCT01602055 Clinical Trial

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

Fasting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01602055
Other study ID # XXI/32/CL/2009
Secondary ID
Status Completed
Phase Phase 1
First received May 15, 2012
Last updated May 17, 2012
Start date October 2010
Est. completion date November 2010

Study information
Verified date May 2012
Source PT Novell Pharmaceutical Laboratories
Contact n/a
Is FDA regulated No
Health authority Indonesia: National Agency of Drug and Food Control
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Azithromycin
Single dose 500 mg of film coated tablet
• Azithromycin
Single dose 500 mg of film coated tablet

Locations
Country Name City State
Indonesia PT Clinisindo Laboratories Jakarta

Sponsors (1)
Lead Sponsor Collaborator
PT Novell Pharmaceutical Laboratories

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL) 30 days No
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