Official Title: “A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• Drug: Ramipril
  • 10 mg capsule

Primary Measures

• Bioequivalence
  • Time Frame: Baseline, two-period, 7 day washout
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Roxane Laboratories

Overall Clinical Trial Officials and Contacts

Daniel V Freeland, D.O. Principal Investigator CEDRA Clinical Research, LLC  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702091

Study ID Number: RAMI-C10-PVFS-1

ClinicalTrials.gov Identifier: NCT00702091

Health Authority: United States: Food and Drug Administration