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

May 17, 2012 updated by: PT Novell Pharmaceutical Laboratories
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • PT Clinisindo Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Novell Pharmaceutical Laboratories

Investigators

  • Principal Investigator: Yahdiana Harahap, Prof, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (ESTIMATE)

May 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 17, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XXI/32/CL/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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