Completed
Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A In Healthy Subjects
What is being tested
Atorvastatin
+ Hydrochlorothiazide + Losartan
+ Hydrochlorothiazide + Losartan + Atorvastatin
Drug
Who is being recruted
From 18 to 55 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: February 2013
Summary
Principal SponsorAzidus Brasil
Last updated: October 31, 2022
Sourced from a government-validated database.Claim as a partner
Study start date: February 28, 2013
Actual date on which the first participant was enrolled.The pharmacokinetic profile of the drug will also be assessed by comparing the serum concentration of active metabolites following: O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT carboxylic acid (E-3174, LS-CA): active metabolite of LS
Principal SponsorAzidus Brasil
Last updated: October 31, 2022
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits
BMI >= 18.5 and <= 30
Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways
11 exclusion criteria prevent from participating
Acute illness during the 07 days preceding the start of the study
Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results
At the discretion of the Principal Investigator of the study
Chronic disease that determine drug delivery, such as hypertension, diabetes or any other that requires continuous use of any medicine, including use of vitamins, mineral supplements and OTCs (over-the-counter)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorCitalor (Atorvastatin) - Pfizer
Group II
Active ComparatorHyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
Group III
ExperimentalPolipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, BrazilOpen LAL Clínica Pesquisa e Desenvolvimento Ltda in Google MapsCompletedOne Study Center