Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692717
• Other study ID #: ALHHYP0512OR-I
• Secondary ID: Version 01 May 2
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2013
• Est. completion date: May 31, 2013

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 31, 2013
• Est. primary completion date: May 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Atorvastatin
10 mg
• Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
• Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg

Locations

Country	Name	City	State
Brazil	LAL Clínica Pesquisa e Desenvolvimento Ltda	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.