To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed

Sandoz

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions.; Drug: Lisinopril 40 mg Tablet under fed conditions.; Drug: Lisinopril 40 mg Tablet under fasting conditions.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883506

00104

Details and patient eligibility

About

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and Fed.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 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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24 participants in 3 patient groups

1

Experimental group

Description:

Lisinopril 40 mg Tablet under fed conditions.

Treatment:

Drug: Lisinopril 40 mg Tablet under fed conditions.

2

Active Comparator group

Description:

Lisinopril 40 mg Tablet (Zestril)

Treatment:

Drug: Lisinopril 40 mg Tablet (Zestril) under fed conditions.

3

Experimental group

Description:

Lisinopril 40 mg Tablet under fasting conditions.

Treatment:

Drug: Lisinopril 40 mg Tablet under fasting conditions.