Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

N/ACompletedNCT00702260

Roxane Laboratories39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

RamiprilDRUG

10 mg capsule

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 Ramipril or any comparable or similar product.

Locations (1)

CEDRA Clinical Research, LLC

Austin, Texas, United States

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, two-period, 7 day washout

Data from ClinicalTrials.gov

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