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Sponsors and Collaborators: |
Mylan Pharmaceuticals Genpharm ULC |
---|---|
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650221 |
The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions.
Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Therapeutic Equivalency |
Drug: Pravastatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects |
Enrollment: | 43 |
Study Start Date: | June 2003 |
Study Completion Date: | July 2003 |
Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Pravastatin
Single-dose 80 mg immediate-release oral tablet
|
2: Active Comparator |
Drug: Pravastatin
Single-dose 80 mg immediate-release tablet
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Biovail Contract Research | |
Toronto, Ontario, Canada, M1L 4S4 |
Principal Investigator: | Paul Tam, MD | Biovail Contract Research |
Responsible Party: | Genpharm ULC ( Elliot Offman, Director, Biopharmaceutics ) |
Study ID Numbers: | 2721 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650221 History of Changes |
Health Authority: | Canada: Health Canada |
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 |