To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00946621 |
Recruitment Status :
Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Ramipril 10 mg Capsule (Sandoz) Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | November 2004 |
Actual Study Completion Date : | November 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Ramipril 10 mg Capsule (Sandoz)
|
Drug: Ramipril 10 mg Capsule (Sandoz) |
Active Comparator: 2
Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)
|
Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical) |
- Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946621
Principal Investigator: | Steven Herrmann, M.D., PhD | Cetero Research, San Antonio |
Responsible Party: | Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. |
ClinicalTrials.gov Identifier: | NCT00946621 |
Other Study ID Numbers: |
B043724 |
First Posted: | July 27, 2009 Key Record Dates |
Last Update Posted: | March 28, 2017 |
Last Verified: | July 2009 |
Hypertension Vascular Diseases Cardiovascular Diseases Ramipril Angiotensin-Converting Enzyme Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |