MedTrace Logo

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

NCT05090449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-10-22

No results posted yet for this study

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)

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Araceli G Medina Nolasco, M.D · Investigación Farmacológica y Biofarmacéutica, S.A.P.I. de C.V.

  • Liz J Medina Reyes, M.D · Investigación Farmacológica y Biofarmacéutica, S.A.P.I. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-04-08
Completion
2020-05-25

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090449 on ClinicalTrials.gov