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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00829452 |
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule mixed with applesauce under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Ramipril 10 mg capsule Drug: Altace® 10 mg capsule |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Randomized, 2-Way Crossover Bioequivalence Study of Ramipril 10 mg Capsule and Altace® Administered as the Content of 1 x 10 mg Capsule Mixed With Applesauce in Healthy Subjects Under Fasting Conditions. |
Enrollment: | 40 |
Study Start Date: | August 2004 |
Study Completion Date: | October 2004 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Ramipril 10 mg capsule
1 x 10 mg
|
2: Active Comparator |
Drug: Altace® 10 mg capsule
1 x 10 mg
|
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver of kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of hte drug.
Canada, Quebec | |
Anapharm Inc. | |
Sainte-Foy, Quebec, Canada, G1V 2K8 | |
Anapharm Inc. | |
Montreal, Quebec, Canada, H2X 2H9 |
Principal Investigator: | Richard Larouche, M.D. | Anapharm |
Study ID Numbers: | 40181 |
Study First Received: | January 23, 2009 |
Results First Received: | July 2, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00829452 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Angiotensin-Converting Enzyme Inhibitors Cardiovascular Agents Healthy |
Antihypertensive Agents Ramipril Protease Inhibitors |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Ramipril Protease Inhibitors |