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Completed

NCT Number: NCT01692717

Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide

The objective of this clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LAL Clínica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
  • Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits;
  • BMI ≥ 18.5 and ≤ 30.

Exclusion criteria

  • Participation in clinical trials in the 12 months preceding the survey;
  • History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
  • Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
  • Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
  • Acute illness during the 07 days preceding the start 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);
  • Having made regular use of medication in the last 02 weeks before the onset of the study. The use of any medication that does not interfere with the physician's judgment on the pharmacokinetics of the drug under study, will not be considered as an exclusion criterion.
  • Use of medications that interact with any medications association;
  • History of or current use for at least 12 months of tobacco;
  • Current or previous history (under 12 months) of illicit drug use;
  • At the discretion of the Principal Investigator of the study.

Treatment and study plan

atorvastatin

Drug

10 mg

Other names: Citalor

Hydrochlorothiazide + Losartan

Drug

12.5 mg + 50 mg

Other names: Hyzaar

Hydrochlorothiazide + Losartan + Atorvastatin

Drug

12.5 mg + 50 mg + 10 mg

Other names: Polipílula

Primary outcomes

  1. The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2.

    Time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.

Secondary outcomes

  1. Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2.

    Time frame: 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00.

Sponsors and collaborators

Lead sponsor

Azidus Brasil

Industry

Registry information

Official study title

Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A In Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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