Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide

Azidus

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Hydrochlorothiazide + Losartan; Drug: Atorvastatin; Drug: Hydrochlorothiazide + Losartan + Atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01692717

ALHHYP0512OR-I

Version 01 May 28, 2012 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Participation in clinical trials in the 12 months preceding the survey;
2. History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
3. Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
4. Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
5. Acute illness during the 07 days preceding the start of the study;
6. 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);
7. 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.
8. Use of medications that interact with any medications association;
9. History of or current use for at least 12 months of tobacco;
10. Current or previous history (under 12 months) of illicit drug use;
11. At the discretion of the Principal Investigator of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Atorvastatin

Active Comparator group

Description:

Citalor (Atorvastatin) - Pfizer

Treatment:

Drug: Hydrochlorothiazide + Losartan + Atorvastatin

Drug: Hydrochlorothiazide + Losartan

Drug: Atorvastatin

Hydrochlorothiazide + Losartan

Active Comparator group

Description:

Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme

Treatment:

Drug: Hydrochlorothiazide + Losartan + Atorvastatin

Drug: Hydrochlorothiazide + Losartan

Drug: Atorvastatin

Atorvastatin + Hydrochlorothiazide + Losartan

Experimental group

Description:

Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas

Treatment:

Drug: Hydrochlorothiazide + Losartan + Atorvastatin

Drug: Hydrochlorothiazide + Losartan

Drug: Atorvastatin