Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Clarithromycin ER 500 mg tablets
* Drug: BIAXIN® XL 500 mg tablets


Participation Criteria
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Eligibility Criteria
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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: 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. 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: History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months. History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness. History of treatment for any gastrointestinal disorder within the past 5 years. History of treatment for asthma within the past five (5) years. History of diarrhea within 24 hours prior to dosing. Females who are pregnant or lactating. 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: Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clarithromycin (test) First<br> | Drug: Clarithromycin ER 500 mg tablets<br>* 1 x 500 mg<br>|
| Active Comparator: Biaxin® XL (reference) First<br> | Drug: BIAXIN® XL 500 mg tablets<br>* 1 x 500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration | Bioequivalence based on Cmax | Blood samples collected over 36 hour period | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | 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 | Bioequivalence based on AUC0-t | Blood samples collected over 36 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Healthy Subjects