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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946621
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-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 ] [ Designated as safety issue: Yes ]

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 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946621

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946621     History of Changes
Other Study ID Numbers: B043724
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014