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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00829530 |
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 1 x 10 mg capsule under fed 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 1 x 10 mg Capsule in Healthy Subjects Under Fed 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
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2: Active Comparator |
Drug: Altace® 10 mg capsule
1 x 10 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:
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: | 40180 |
Study First Received: | January 23, 2009 |
Results First Received: | July 2, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00829530 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bioequivalence Healthy Subjects |
Malnutrition 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 |