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

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ClinicalTrials.gov Identifier: NCT00946465
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under fasting conditions.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Ramipril 10 Capsule (Sandoz) Drug: Altace (Ramipril) 10 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 Fasting Conditions
Study Start Date : October 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril
U.S. FDA Resources

Arm Intervention/treatment
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)



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


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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.

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

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 Posted: July 27, 2009    Key Record Dates
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