CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Chlorthalidone (HIGROTON® 50) +3 moredrug
Likely dose
Chlorthalidone (HIGROTON® 50) 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05090449
NCT05090449Phase 1Completed

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

Laboratorios Silanes S.A. de C.V.·interventional·Posted Oct 22, 2021·Updated Oct 22, 2021

In Brief

A Phase 1 clinical trial evaluating Chlorthalidone (HIGROTON® 50), Losartan (COZZAR®), and 2 other interventions for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesMexico
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedOct 22, 2021
Enrollment StartMay 1, 2019
Primary CompletionApr 8, 2020
Study CompletionMay 25, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.7 years ago

Interventions

Chlorthalidone (HIGROTON® 50)drug

Tablets with 50mg of Chlorthalidone, product de Sandoz, S.A. de C.V.

Losartan (COZZAR®)drug

Losartan potassium 100 mg tablet, a product of Schering-Plough, S.A. C.V.

A1+ A2 Co-administration of Chlorthalidone and Losartandrug

50mg chlorthalidone + 100 mg losartan potassium

Chlorthalidone + Losartan Fixed-Dose combinationdrug

Tablets with fixed combination of Chlorthalidone 25 mg and Losartan Potassium