Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed conditions...
Brief Summary
Official Title: “A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions”
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed 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: January 2005
Intervention(s) in this Clinical Trial
- Drug: Ramipril
- 10 mg capsule
Outcome Measures for this Clinical Trial
Primary Measures
- Bioequivalence
- Time Frame: Baseline, two-period, 7 day washout
Safety Issue?: No
- Time Frame: Baseline, two-period, 7 day washout
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 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
Clinical Trial Investigator Information
Lead Investigator: Roxane Laboratories Industry
Overall Clinical Trial Officials and Contacts
Daniel V Freeland, D.O. Principal Investigator CEDRA Clinical Research
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702260
Study ID Number: RAMI-C10-PVFD-1
ClinicalTrials.gov Identifier: NCT00702260
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00702260
