Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions

Sponsor

Roxane Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT01012687

Collaborator

(none)

Enrollment

Location

Duration (Days)

48.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: perindopril erbumine	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 Fasting Conditions

Study Start Date :

Apr 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:

NCT01012687

Other Study ID Numbers:

PERI-T8-PVFS-1

First Posted:

Nov 13, 2009

Last Update Posted:

Jan 23, 2018

Last Verified:

Jan 1, 2018

Additional relevant MeSH terms:

Essential Hypertension

Perindopril

Study Results

No Results Posted as of Jan 23, 2018