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Sponsored by: |
Teva Pharmaceuticals USA |
---|---|
Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00834379 |
The objective of this study is to compare the relative bioavailability of pravastatin sodium 40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: pravastatin sodium Drug: Pravachol® |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions |
Enrollment: | 58 |
Study Start Date: | September 2000 |
Study Completion Date: | September 2000 |
Primary Completion Date: | September 2000 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: pravastatin sodium
40 mg Tablet
|
2: Active Comparator |
Drug: Pravachol®
40 mg tablet
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
At the end of the study the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
Adequate blood and urine samples should be obtained within 21 days before the beginning of the first period and at the end of the trial for clinical laboratory measurements.
Clinical laboratory measurements will include the following:
Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential)
Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline phosphatase
Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells
HIV Screen: (pre-study only)
Hepatitis-B, C Screen: (pre-study only)
Drugs of Abuse Screen: (pre-study and at each dosing period check-in)
Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Exclusion Criteria
Study ID Numbers: | B006511 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00834379 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Bioequivalence Healthy Subjects |
Antimetabolites Pravastatin Antilipemic Agents |
Anticholesteremic Agents Healthy Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Antimetabolites Pravastatin Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |