Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

This study has been completed.

First Received: June 19, 2008 No Changes Posted

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00702260

Purpose

The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed conditions.

Condition	Intervention
Hypertension	Drug: Ramipril

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, two-period, 7 day washout ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	January 2005
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Intervention Details:

10 mg capsule

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702260

Locations

United States, Texas
CEDRA Clinical Research, LLC
Austin, Texas, United States, 78759

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Daniel V Freeland, D.O.

CEDRA Clinical Research

More Information

No publications provided

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, DRA-MA )
Study ID Numbers:	RAMI-C10-PVFD-1
Study First Received:	June 19, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702260 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Malnutrition
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Agents

Antihypertensive Agents
Ramipril
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ramipril
Protease Inhibitors
Hypertension

ClinicalTrials.gov processed this record on September 09, 2009