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To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00946465
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  Purpose
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting conditions.

Condition Intervention Phase
Hypertension Drug: Ramipril 10 Capsule (Sandoz) Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical) Phase 1

Study Type: Interventional
Study Design: 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 Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 30 days ]

Enrollment: 48
Study Start Date: October 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ramipril 10 Capsule (Sandoz)
Drug: Ramipril 10 Capsule (Sandoz)
Active Comparator: 2
Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)
Drug: Altace (Ramipril) 10 Capsule (Aventis Pharmaceutical)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00946465


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Steven Herrmann, M.D., PhD Cetero Research, San Antonio
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946465     History of Changes
Other Study ID Numbers: B043723
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
Last Verified: July 2009

Additional relevant MeSH terms:
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents