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

This study has been completed.
Information provided by (Responsible Party):
PT Novell Pharmaceutical Laboratories Identifier:
First received: May 15, 2012
Last updated: May 17, 2012
Last verified: May 2012
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

Condition Intervention Phase
Fasting Drug: Azithromycin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by PT Novell Pharmaceutical Laboratories:

Primary Outcome Measures:
  • Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL) [ Time Frame: 30 days ]

Enrollment: 24
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azivol Drug: Azithromycin
Single dose 500 mg of film coated tablet
Active Comparator: Zithromax Drug: Azithromycin
Single dose 500 mg of film coated tablet


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01602055

PT Clinisindo Laboratories
Jakarta, Indonesia
Sponsors and Collaborators
PT Novell Pharmaceutical Laboratories
Principal Investigator: Yahdiana Harahap, Prof Indonesia University
  More Information

Responsible Party: PT Novell Pharmaceutical Laboratories Identifier: NCT01602055     History of Changes
Other Study ID Numbers: XXI/32/CL/2009
Study First Received: May 15, 2012
Last Updated: May 17, 2012 processed this record on August 16, 2017