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

Randomized, 2-Way Crossover, Bioequivalence Study of Eon Labs Manufacturing Inc. (USA) and Zeneca (USA) (Zestril) 40 mg Lisinopril Tablet Administered as a 1 x 40 mg Tablet in Health Adult Males Under Fasting Conditions.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00883064

Enrollment

Registered

2009-04-17

Start date

2000-03-31

Completion date

2000-04-30

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 54 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on AUC and Cmax	23 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026