Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablets under fasting conditions...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2007
Intervention(s) in this Clinical Trial
- Drug: perindopril erbumine
- 8 mg tablet
Outcome Measures for this Clinical Trial
Primary Measures
- bioequivalence determined by statistical comparison Cmax
- Time Frame: 20 Days
Safety Issue?: No
- Time Frame: 20 Days
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Roxane Laboratories Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01012687
