NCT05090449

Non-interaction Study of Chlorthalidone and Losartan in Fixed Combination, in Healthy Subjects, Under Fasting Conditions

No Pharmacokinetic Interaction Between Chlorthalidone and Losartan, in Healthy Volunteers Under Fasting Conditions, Administered in Fixed Combination Against Individual Components Administered Jointly and Separately

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Monocentric study of no pharmacokinetic interaction between chlorthalidone and losartan, with an open, randomized, single-dose design with four periods, four sequences and crossover in healthy volunteers, under fasting conditions, administered in fixed combination (Test product of Laboratorios Silanes, SA de CV) against the individual components administered jointly and separately (Higroton® 50, a product of Sandoz, SA de CV and Cozaar® , a product of Schering-Plow, SA de CV)

Detailed description

The study was designed to recruit 36 healthy subjects, which were randomized for this study contemplating losses. All the volunteers whose data allowed at least one comparison to be made were included in the corresponding statistical analysis. The objective was to statistically compare the bioavailability of chlorthalidone (at normalized dose) and losartan potassium, in a non-interaction pharmacokinetic study after single-dose oral administration of a product with the fixed combination of active ingredients with respect to the individual components administered together and separately in healthy fasting volunteers. As a secondary objective, the tolerability of the presentations was evaluated based on the registry of adverse events at the end of the four study periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Chlorthalidone (HIGROTON® 50)	Tablets with 50mg of Chlorthalidone, product de Sandoz, S.A. de C.V.
DRUG	Losartan (COZZAR®)	Losartan potassium 100 mg tablet, a product of Schering-Plough, S.A. C.V.
DRUG	A1+ A2 Co-administration of Chlorthalidone and Losartan	50mg chlorthalidone + 100 mg losartan potassium
DRUG	Chlorthalidone + Losartan Fixed-Dose combination	Tablets with fixed combination of Chlorthalidone 25 mg and Losartan Potassium

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-04-08
• Completion: 2020-05-25
• First posted: 2021-10-22
• Last updated: 2021-10-22

Locations

1 site across 1 country: Mexico