Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00840411
First received: February 6, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

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 66 adult subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Clarithromycin ER 500 mg tablets
Drug: BIAXIN® XL 500 mg tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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 66 Fasted, Healthy, Adult Subjects

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 36 hour period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: September 2002
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clarithromycin (test) First Drug: Clarithromycin ER 500 mg tablets
1 x 500 mg
Active Comparator: Biaxin® XL (reference) First Drug: BIAXIN® XL 500 mg tablets
1 x 500 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

C. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840411

Locations
United States, Missouri
Gateway Medical Research
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Ali Ziaee, M.D. Gateway Medical Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00840411     History of Changes
Other Study ID Numbers: 02197
Study First Received: February 6, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014