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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Atorvastatin; Drug: Hydrochlorothiazide + Losartan; Drug: Hydrochlorothiazide + Losartan + Atorvastatin

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atorvastatin; Citalor (Atorvastatin) - Pfizer	Drug: Atorvastatin; 10 mg; Other Names: Citalor; Drug: Hydrochlorothiazide + Losartan; 12.5 mg + 50 mg; Other Names: Hyzaar; Drug: Hydrochlorothiazide + Losartan + Atorvastatin; 12.5 mg + 50 mg + 10 mg; Other Names: Polipílula
Active Comparator: Hydrochlorothiazide + Losartan; Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme	Drug: Atorvastatin; 10 mg; Other Names: Citalor; Drug: Hydrochlorothiazide + Losartan; 12.5 mg + 50 mg; Other Names: Hyzaar; Drug: Hydrochlorothiazide + Losartan + Atorvastatin; 12.5 mg + 50 mg + 10 mg; Other Names: Polipílula
Experimental: Atorvastatin + Hydrochlorothiazide + Losartan; Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas	Drug: Atorvastatin; 10 mg; Other Names: Citalor; Drug: Hydrochlorothiazide + Losartan; 12.5 mg + 50 mg; Other Names: Hyzaar; Drug: Hydrochlorothiazide + Losartan + Atorvastatin; 12.5 mg + 50 mg + 10 mg; Other Names: Polipílula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Azidus Brasil

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2013
• Primary Completion (Actual): May 31, 2013
• Study Completion (Actual): May 31, 2013

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 25, 2012

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Natriuretic Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Atorvastatin; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: ALHHYP0512OR-I; Version 01 May 28, 2012 (Other Identifier: LAL Clínica)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No