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Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.

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ClinicalTrials.gov Identifier: NCT00840216
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : July 21, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE February 6, 2009
First Posted Date  ICMJE February 10, 2009
Results First Submitted Date  ICMJE June 18, 2009
Results First Posted Date  ICMJE July 21, 2009
Last Update Posted Date September 11, 2009
Study Start Date  ICMJE August 2002
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2009)
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 36 hour period ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 36 hour period ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration [ Time Frame: Blood samples collected over 36 hour period ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT00840216 on ClinicalTrials.gov Archive Site
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 Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
Official Title  ICMJE A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Relative Bioavailability of a Test Extended Release Tablet Formulation of Clarithromycin (500 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Biaxin® XL Filmtab) in 22 Fed, Healthy, Adult Subjects
Brief Summary The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test population of 22 adult subjects under fed conditions.
Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Clarithromycin ER 500 mg tablets
    1 x 500 mg
  • Drug: BIAXIN® XL 500 mg tablets
    1 x 500 mg
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Clarithromycin ER 500 mg tablets
  • Active Comparator: 2
    Intervention: Drug: BIAXIN® XL 500 mg 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
Actual Enrollment  ICMJE
 (submitted: February 9, 2009)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2002
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Sex: Males or females who are surgically sterile or have been post-menopausal for at least 6 months; similar proportions of each preferred.
  • Age: At least 18 years.
  • Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subjects may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:

    1. Laboratory Tests:

      Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Nz, K, Cl), fasting blood glucose, BUN, bilirubin,m creatinine, AST, ALT, LD, alkaline phosphatase and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in. Post-menopausal females will have an FSH (Follicle Stimulating Hormone) level performed to confirm post-menopausal status.

      Laboratory values which are greater than ±20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.

    2. Electrocardiogram

A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.

  • Subjects must read and sign the Consent Form.

Exclusion Criteria

  • Subjects not complying with the above inclusion criteria must be excluded from the study.
  • In addition, any one of the conditions listed below will exclude a subject from the study:

    1. History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
    2. History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
    3. History of treatment for any gastrointestinal disorder within the past 5 years.
    4. History of treatment for asthma within the past five (5) years.
    5. History of diarrhea within 24 hours prior to dosing.
    6. Females who are pregnant or lactating.
    7. History of hypersensitivity to clarithromycin or any macrolide antibiotic.
  • Conditions upon screening which might contraindicate or require that caution be used in the administration of dexmethylphenidate hydrochloride, including:

    1. Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.
    2. Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
  • Inability to read and/or sign the consent form.
  • Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
  • Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
  • Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.). Three (3) consecutive months abstinence is required.
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 NCT00840216
Other Study ID Numbers  ICMJE 02198
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Teva Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali Ziaee, MD Gateway Medical Research
PRS Account Teva Pharmaceuticals USA
Verification Date September 2009

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