Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions

Roxane Laboratories

Status: Completed

Conditions: Essential Hypertension

Treatments: Drug: perindopril erbumine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012687

PERI-T8-PVFS-1

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)