Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Ramipril (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Daniel V Freeland, D.O., Principal Investigator, Affiliation: CEDRA Clinical Research, LLC
Summary
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under
fasting conditions.
Clinical Details
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
CEDRA Clinical Research, LLC, Austin, Texas 78759, United States
Additional Information
Starting date: January 2005
Ending date: January 2005
Last updated: June 19, 2008
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