To Demonstrate the Relative Bioavailability Study of Ramipril 10 mg Capsules Under Non-Fasting Conditions

Phase 1CompletedNCT00946621

Sandoz48 enrolled

Overview

To demonstrate the relative bioavailability study of Ramipril 10 mg capsules under non-fasting conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Ramipril 10 mg Capsule (Sandoz)DRUG

Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 30 days

Data from ClinicalTrials.gov

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