Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions

Roxane Laboratories48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Hypertension

Interventions

perindopril erbumineDRUG

8 mg tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novum Pharmaceutical Research Services

Houston, Texas, United States

Outcomes

Primary Outcomes

bioequivalence determined by statistical comparison Cmax

Time frame: 20 Days

Data from ClinicalTrials.gov

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