Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions

Roxane Laboratories

Status: Completed

Conditions: Hypertension

Treatments: Drug: Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00702091

RAMI-C10-PVFS-1

Details and patient eligibility

About

The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fasting conditions.

Enrollment: 39 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 Ramipril or any comparable or similar product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)