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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PT Novell Pharmaceutical Laboratories
ClinicalTrials.gov Identifier:
NCT01602055
First received: May 15, 2012
Last updated: May 17, 2012
Last verified: May 2012
History of Changes

May 15, 2012
May 17, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01602055 on ClinicalTrials.gov Archive Site
Not Provided
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A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects
Not Provided

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Fasting
Drug: Azithromycin
Single dose 500 mg of film coated tablet
  • Experimental: Azivol
    Intervention: Drug: Azithromycin
  • Active Comparator: Zithromax
    Intervention: Drug: Azithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01602055
XXI/32/CL/2009
Yes
PT Novell Pharmaceutical Laboratories
PT Novell Pharmaceutical Laboratories
Not Provided
Principal Investigator: Yahdiana Harahap, Prof University of Indonesia
PT Novell Pharmaceutical Laboratories
May 2012

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