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Trial record 39 of 428 for:    CLARITHROMYCIN

Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

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: NCT00648830
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Sponsor:
Collaborator:
Genpharm ULC
Information provided by:
Mylan Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date April 1, 2008
Study Start Date  ICMJE May 2004
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
Pharmacokinetic parameters (AUC & Cmax) [ Time Frame: within 14 days ]
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 Comparative Bioavailability Study of Clarithromycin 250 mg Tablets
Official Title  ICMJE Randomized Single Dose Crossover Replicate Comparative Bioavailability Study of Clarithromycin 250 mg Tablets in Healthy Male and Female Volunteers Under Fasted Conditions
Brief Summary

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this four-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 250 mg tablets are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered under fasted conditions.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Procedure: Clarithromycin
    Single-dose of Clarithromycin 250 mg oral immediate-release tablets
    Other Name: Biaxin®, Biaxin® Filmtabs
  • Drug: Clarithromycin
    single-dose 250 mg immediate-release oral tablets
Study Arms  ICMJE
  • Experimental: 1
    Clarithromycin 250 mg immediate-release oral tablet
    Intervention: Drug: Clarithromycin
  • Active Comparator: 2
    Biaxin® (Clarithromycin) 250 mg tablet
    Intervention: Procedure: Clarithromycin
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
Actual Enrollment  ICMJE
 (submitted: March 31, 2008)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2004
Actual Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects meeting all of the following criteria may be included in the study:

Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly signed by the volunteer

Males or females aged of at least 18 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/m2

Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)

Healthy according to the laboratory results and physical examination

Light , non or ex smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex smokers are defined as someone who completely stopped smoking for at least 3 months

Exclusion Criteria:

Significant history of hypersensitivity to clarithromycin, erythromycin, other macrolide antibacterial agents or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs

Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects

Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease

Presence of significant heart disease or disorder according to ECG

Females who are pregnant, lactating or are likely to become pregnant during the study

Females of childbearing potential or females taking systemic contraceptives who refuse to use one of the acceptable contraceptive regimen (described in section 5.4.9) throughout the study

Positive HCG beta serum pregnancy test before or during the study

Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)

Any clinically significant illness in the previous 28 days before day 1 of this study

Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)

Participation in another clinical trial in the previous 28 days before day 1 of this study

Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study

Positive urine screening of drugs of abuse (drugs listing is presented in section 6.1.1.4)

Positive results to HIV, HBsAg or anti-HCV tests

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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00648830
Other Study ID Numbers  ICMJE CAI-P4-057
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elliot Offman, Director, Biopharmaceutics, Genpharm ULC
Study Sponsor  ICMJE Mylan Pharmaceuticals
Collaborators  ICMJE Genpharm ULC
Investigators  ICMJE
Principal Investigator: Eric Sicard, M.D. Algorithme Pharma Inc
PRS Account Mylan Pharmaceuticals
Verification Date March 2008

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