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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00830258 |
The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a single-dose in healthy subjects under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Pravastatin sodium 80 mg tablets Drug: Pravachol® 80 mg tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Single-Dose, Comparative, Bioavailability Study of Two Formulations of Pravastatin Sodium 80 mg Tablets Under Fasting Conditions |
Enrollment: | 60 |
Study Start Date: | April 2005 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Pravastatin sodium 80 mg tablets
1 x 80 mg
|
2: Active Comparator |
Drug: Pravachol® 80 mg tablets
1 x 80 mg
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Negative for:
Females who participate in this study are:
Exclusion Criteria:
Known history or presence of:
Canada, Ontario | |
Pharma Medica Research Inc. | |
Toronto, Ontario, Canada, M1R 5A3 |
Principal Investigator: | Xueyu (Eric) Chen, M.D.; Ph.D ; FRCP (C) | Pharma Medica Research Inc. |
Study ID Numbers: | 2005-971 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830258 History of Changes |
Health Authority: | United States: Institutional Review Board |
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 |