NCT05061901

Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions

Randomized Crossover 2 Period Single Dose Bioequivalence Study of 2 Formulations Lisinopril Tab. 20mg (Pharmtechnology LLC,Belarus) and Zestril® Tab. 20mg (Avara Reims Pharmaceutical Services, France) in Healthy Volunteers Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Zestril®, 20 mg) or the test (Lisinopril, 20 mg) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Lisinopril tablet 20 mg	Lisinopril is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 20 mg of lisinopril.
DRUG	Zestril® tablet 20 mg	Zestril® is manufactured by Avara Reims Pharmaceutical Services, France. Each tablet contains 20 mg of lisinopril.

Timeline

• Start date: 2021-10-06
• Primary completion: 2021-11-06
• Completion: 2021-11-06
• First posted: 2021-09-30
• Last updated: 2022-07-07

Locations

1 site across 1 country: Russia