Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

• ClinicalTrials.gov Identifier: NCT00836706
• Recruitment Status: Completed
• First Posted: February 4, 2009
• Results First Posted: July 21, 2009
• Last Update Posted: September 11, 2009
• Sponsor: Teva Pharmaceuticals USA
• Information provided by: Teva Pharmaceuticals USA

Tracking Information

• First Submitted Date: February 2, 2009
• First Posted Date: February 4, 2009
• Results First Submitted Date: June 18, 2009
• Results First Posted Date: July 21, 2009
• Last Update Posted Date: September 11, 2009
• Study Start Date: July 2002
• Actual Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2009)

• Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 48 hour period ]
• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 48 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 48 hour period ]

• Original Primary Outcome Measures (submitted: February 2, 2009): Bioequivalence based on Cmax and AUC [ Time Frame: 10 days ]
• Change History: Complete list of historical versions of study NCT00836706 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clarithromycin 500 mg Tablets Under Non-Fasting Conditions
• Official Title: A Relative Bioavailability Study of 500 mg Clarithromycin Tablets Under Non-Fasting Conditions
• Brief Summary: This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects under non-fasting conditions.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
• Condition: Healthy

Intervention

• Drug: clarithromycin
  500 mg Tablet
• Drug: BIAXIN®
  500 mg Tablet

Study Arms

• Experimental: Clarithromycin (test)
  Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
  Intervention: Drug: clarithromycin
• Active Comparator: Biaxin®
  Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period
  Intervention: Drug: BIAXIN®

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2009): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2002
• Actual Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.

Each subject will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.

The screening clinical laboratory procedures will include:

HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens URINALYSIS: by dipstick; full microscopic examination if dipstick positive URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine SERUM PREGNANCY SCREEN (female subjects only) FOLLICLE STIMULATING HORMONE (FSH; female subjects only): verify postmenopausal status

If female and :

is postmenopausal for at least 1 year; or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

Subjects with a recent history of drug or alcohol addiction or abuse. Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).

Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.

Subjects demonstration a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen.

Subjects demonstrating a positive drug abuse screen when screened for this study.

Female subjects who are currently breast feeding. Female subjects who are demonstrating a positive pregnancy screen. Subjects with a history of allergic response(s) to Clarithromycin or related drugs.

Subjects with a history of clinically significant allergies including drug allergies.

Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).

Subjects who currently use or reports using tobacco or nicotine-containing products within 90 days prior to Period I dosing.

Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.

Subjects who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will by advised not to donate blood for four weeks after completing the study.

Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.

Subjects who report receiving any investigational drug within 30 days prior to Period I dosing.

Subjects who report taking any prescription medication in the 14 days prior to Period I dosing, with the exception of topical products without systemic absorption.

Subjects who have been on an abnormal diet during the 28 days prior to Period I dosing.

Subjects who report an intolerance of direct venipuncture.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00836706
• Other Study ID Numbers: R02-664
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Teva Pharmaceuticals USA
• Collaborators: Not Provided

Investigators

• Principal Investigator: James D Carlson, Pharm. D.; PRACS

• PRS Account: Teva Pharmaceuticals USA
• Verification Date: September 2009