To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA); Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883064

00102

Details and patient eligibility

About

To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 54 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)

---

32 participants in 2 patient groups

1

Experimental group

Description:

Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)

Treatment:

Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)

2

Active Comparator group

Description:

Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)

Treatment:

Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)