Official Title: “A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Perindopril Erbumine Tablets 8 mg Under Fasting Conditions”

The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablets under fasting conditions.

Study Type: Interventional

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

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: perindopril erbumine
  • 8 mg tablet

Primary Measures

• bioequivalence determined by statistical comparison Cmax
  • Time Frame: 20 Days
    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 perindopril 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

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01012687

Study ID Number: PERI-T8-PVFS-1

ClinicalTrials.gov Identifier: NCT01012687

Health Authority: United States: Institutional Review Board