Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

Study Overview
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Brief Summary
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This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80 mg tablet)in healthy adult male subjects administered under non-fasting conditions.

Detailed Description
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Detailed Description Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.

Official Title
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A Relative Bioavailability Study of 80 mg Pravastatin Sodium Tablets Under Non-Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pravastatin
* Drug: Pravastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Screening Demographics: All subjects selected for this study will be healthy men 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. Screening Procedures: 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 GB 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 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 demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody. Subjects demonstrating a positive drug abuse screen when screened for this study. Subjects with a history of allergic response(s) to pravastatin 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 or report using tobacco products within 90 days of Period I dose administration. Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing. Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be 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 28 days prior to Period I dosing. Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing. Subjects who report an intolerance of direct venipuncture. Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Pravastatin<br>Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period | Drug: Pravastatin<br>* 80 mg Tablet<br>|
| Active Comparator: Pravachol®<br>Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period | Drug: Pravastatin<br>* 80 mg Tablets<br>* Other names: Pravachol® 80 mg Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration - Pravastatin in Plasma | Bioequivalence based on Cmax | Blood samples collected over 16 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 16 hour period | 
| AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) | Bioequivalence based on AUC0-t | Blood samples collected over 16 hour period | 

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