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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA); Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)

• Registration Number: NCT00883064
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2000-04
• Study Completion: 2000-04
• Status Verified: 2009-03
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)	Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
2	Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)	Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	23 days