NCT03459911

A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions

A Randomized, Open-label, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover Bioequivalence Study of Test Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus With Reference Cozaar® (Containing Losartan Potassium 100 mg) of "Merck Sharpe & Dohme B.V.", Haarlem, the Netherlands in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Pharmtechnology LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe \& Dohme B.V.", Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety

Detailed description

Total 66 normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 200 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to administration of the study drugs and for four (4) hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour to administration of the study drugs and 1 hour after administration of the study drugs in each period. A total of 29 blood samples will be withdrawn for pharmacokinetic profiling during each study period. The plasma concentrations of losartan and its carboxylic acid metabolite will be measured by a validated LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞, and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-t.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cozaar 100mg Tablet	Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands)
DRUG	Losartan potassium 100mg	Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)

Timeline

• Start date: 2018-02-16
• Primary completion: 2018-03-11
• Completion: 2018-03-16
• First posted: 2018-03-09
• Last updated: 2018-11-02

Locations

1 site across 1 country: India