Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fed Conditions
Sponsor
Roxane Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT01013155
Collaborator
(none)
48
1
Study Details
Study Description
Brief Summary
The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablet under fed conditions
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Perindopril Erbumine Tablets 8 mg Under Fed Conditions
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
May 1, 2007
Actual Study Completion Date
:
May 1, 2007
Outcome Measures
Primary Outcome Measures
- bioequivalence determined by statistical comparison Cmax [20 Days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novum Pharmaceutical Research Services | Houston | Texas | United States | 77042 |
Sponsors and Collaborators
- Roxane Laboratories
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01013155
Other Study ID Numbers:
- PERI-T8-PVFD-1
First Posted:
Nov 13, 2009
Last Update Posted:
Jan 23, 2018
Last Verified:
Jan 1, 2018