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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
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602055

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

No publications provided

Responsible Party: PT Novell Pharmaceutical Laboratories
ClinicalTrials.gov Identifier: NCT01602055     History of Changes
Other Study ID Numbers: XXI/32/CL/2009
Study First Received: May 15, 2012
Last Updated: May 17, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013