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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Collaborator: |
Genpharm ULC |
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648544 |
Purpose
This study was designed to compare the rate and extent of absorption of pravastatin sodium from the following formulations under fed conditions:
Based on the results from this study, these two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fed 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, Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects |
| Enrollment: | 44 |
| Study Start Date: | July 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 oral immediate-release tablet
|
| 2: Active Comparator |
Drug: Pravastatin
Single-dose 80 mg oral immediate-release tablets
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Biovail Contract Reseach | |
| Toronto, Ontario, Canada, M1L 4S4 | |
| Principal Investigator: | Paul Tam, MD | Biovail Contract Research |
More Information
| Responsible Party: | Genpharm ULC ( Elliot Offman, Director, Biopharmaceutics ) |
| Study ID Numbers: | 2722 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00648544 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Antimetabolites Pravastatin Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |