Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

This study has been completed.

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

MedlinePlus related topics: High Blood Pressure

Drug Information available for: 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

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

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

Sponsors and Collaborators

Roxane Laboratories

Investigators

Principal Investigator:

Daniel V Freeland, D.O.

CEDRA Clinical Research

More Information

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
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Malnutrition
Vascular Diseases
Ramipril
Hypertension

Additional relevant MeSH terms:

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

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009