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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Ramipril 10 mg Capsule (Sandoz); Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946621

B043724

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

1

Experimental group

Description:

Ramipril 10 mg Capsule (Sandoz)

Treatment:

Drug: Ramipril 10 mg Capsule (Sandoz)

2

Active Comparator group

Description:

Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)

Treatment:

Drug: Altace (Ramipril) 10 mg Capsule (Aventis Pharmaceutical)