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

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ClinicalTrials.gov Identifier: NCT01602055
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):
PT Novell Pharmaceutical Laboratories

May 15, 2012
May 18, 2012
May 21, 2012
October 2010
November 2010   (Final data collection date for primary outcome measure)
Plasma concentration of azithromycin until 120 h after oral administration of 500 mg Azithromycin tablet (ng/mL) [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01602055 on ClinicalTrials.gov Archive Site
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A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
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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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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Drug: Azithromycin
Single dose 500 mg of film coated tablet
  • Experimental: Azivol
    Intervention: Drug: Azithromycin
  • Active Comparator: Zithromax
    Intervention: Drug: Azithromycin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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PT Novell Pharmaceutical Laboratories
PT Novell Pharmaceutical Laboratories
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Principal Investigator: Yahdiana Harahap, Prof Indonesia University
PT Novell Pharmaceutical Laboratories
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP