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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602055
First Posted: May 18, 2012
Last Update Posted: May 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
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
Intervention Model: Crossover Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
 
NCT01602055
XXI/32/CL/2009
Yes
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PT Novell Pharmaceutical Laboratories
PT Novell Pharmaceutical Laboratories
Not Provided
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