NCT01692717

Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Atorvastatin	10 mg
DRUG	Hydrochlorothiazide + Losartan	12.5 mg + 50 mg
DRUG	Hydrochlorothiazide + Losartan + Atorvastatin	12.5 mg + 50 mg + 10 mg

Timeline

• Start date: 2013-02-28
• Primary completion: 2013-05-31
• Completion: 2013-05-31
• First posted: 2012-09-25
• Last updated: 2022-10-31

Locations

1 site across 1 country: Brazil