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Bioequivalence Study of Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

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.
 
ClinicalTrials.gov Identifier: NCT00774696
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Tracking Information
First Submitted Date  ICMJE October 15, 2008
First Posted Date  ICMJE October 17, 2008
Last Update Posted Date October 17, 2008
Study Start Date  ICMJE December 2002
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
Bioequivalence
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Clarithromycin 500 mg Tablets Under Non-Fasting Conditions
Official Title  ICMJE The Objective of This Study is to Compare the Relative Bioavailability of Clarithromycin 500 mg Tablets (Ranbaxy Laboratories Limited) With That of BIAXIN® 500 mg Tablets in Healthy, Adult Subjects Under Non-Fasting Conditions.
Brief Summary The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under non-fasting conditions.
Detailed Description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioavailability study on clarithromycin formulations comparing clarithromycin 500mg tablets of Ranbaxy Laboratories with Biaxin® tablets 500mg (containing clarithromycin 500 mg)in healthy, adult, human, male subjects under fed conditions Subjects were given a standardized meal starting 30 minutes before their assigned dosing time consisting of one buttered English muffin, one fried egg, one slice of American cheese, one slice of Canadian bacon, 2.45 ounces of hash brown potatoes, six fluid ounces of orange juice, and eight fluid ounces of whole milk.

A single oral dose of clarithromycin 500mg was administered during each period under supervision of a trained Medical Officer.

During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology & biochemical parameters) were performed again at the end of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Drug: clarithromycin 500mg tablets
Study Arms  ICMJE
  • Experimental: 1
    Clarithromycin 500 mg Tablets
    Intervention: Drug: clarithromycin 500mg tablets
  • Active Comparator: 2
    BIAXIN® 500 mg tablets
    Intervention: Drug: clarithromycin 500mg tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 16, 2008)
24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2003
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Source of Subjects: Non-institutionalized subjects consisting of members of the community at large.
  2. Characterization of Study Group

    • All subjects selected for this study will be at least 18 years of age. Female subjects must be unable to become pregnant (postmenopausal for at least 1 year, or surgically sterile).
    • Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examinati°n includes, but is not limited to, blood pressure, general observations, and history.

Each female subject will be given a serum pregnancy test as part of the pre-study screening process. At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.

Drags of Abuse Screen: pre-study and at check-in each study period subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each Subject's case report forms.

Exclusion Criteria:

  1. Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  2. Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  3. Subjects who have a history of allergic responses to theclass of drag being tested (including any penicillin product) should be excluded from the study.
  4. All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures at check-in each study period. Subjects found to have urine concentrations of tested will not be allowed to participate.
  5. Subjects should not have donated blood or plasma for at least (30) days prior to first dosing of the study.

g. Female subjects who are pregnant or who are able (women child bearing potential) to become pregnant during the study not be allowed to participate.

h. All female subjects will be screened for pregnancy at check in each study period. Subjects with positive pr inconclusive results will be withdrawn from the study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00774696
Other Study ID Numbers  ICMJE B025512
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tausif Monif, Ranbaxy Research Laboratories
Study Sponsor  ICMJE Ranbaxy Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ranbaxy Inc.
Verification Date October 2008

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