Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Atorvastatin; Drug: Hydrochlorothiazide + Losartan; Drug: Hydrochlorothiazide + Losartan + Atorvastatin

• Registration Number: NCT01692717
• Lead Sponsor: Azidus Brasil

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-25
• Study Start: 2013-02-28
• Primary Completion: 2013-05-31
• Study Completion: 2013-05-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrochlorothiazide + Losartan	Hydrochlorothiazide + Losartan	Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme
Atorvastatin	Hydrochlorothiazide + Losartan + Atorvastatin	Citalor (Atorvastatin) - Pfizer
Atorvastatin + Hydrochlorothiazide + Losartan	Hydrochlorothiazide + Losartan + Atorvastatin	Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
Atorvastatin + Hydrochlorothiazide + Losartan	Hydrochlorothiazide + Losartan	Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
Hydrochlorothiazide + Losartan	Hydrochlorothiazide + Losartan + Atorvastatin	Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme
Atorvastatin	Hydrochlorothiazide + Losartan	Citalor (Atorvastatin) - Pfizer
Atorvastatin	Atorvastatin	Citalor (Atorvastatin) - Pfizer
Hydrochlorothiazide + Losartan	Atorvastatin	Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme
Atorvastatin + Hydrochlorothiazide + Losartan	Atorvastatin	Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

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

Trial Locations

Locations (1)

LAL Clínica Pesquisa e Desenvolvimento Ltda; 🇧🇷 Valinhos, São Paulo, Brazil