Completed
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.
What is being tested
Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
+ Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)
Drug
Who is being recruted
Cardiovascular Diseases
+ Hypertension
+ Vascular Diseases
From 18 to 54 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: March 2000
Summary
Principal SponsorSandoz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2000
Actual date on which the first participant was enrolled.To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions.
Official TitleRandomized, 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.
Principal SponsorSandoz
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 54 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesHypertensionVascular Diseases
Criteria
1 inclusion criteria required to participate
No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
2 exclusion criteria prevent from participating
Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalLisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
Group II
Active ComparatorLisinopril 40 mg Tablet (Zestril) (Zeneca, USA)
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers