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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01692717
First received: September 21, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Atorvastatin
Drug: Hydrochlorothiazide + Losartan
Drug: Hydrochlorothiazide + Losartan + Atorvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: February 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
Citalor (Atorvastatin) - Pfizer
Drug: Atorvastatin
10 mg
Other Name: Citalor
Drug: Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Other Name: Hyzaar
Drug: Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Name: Polipílula
Active Comparator: Hydrochlorothiazide + Losartan
Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
Drug: Atorvastatin
10 mg
Other Name: Citalor
Drug: Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Other Name: Hyzaar
Drug: Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Name: Polipílula
Experimental: Atorvastatin + Hydrochlorothiazide + Losartan
Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
Drug: Atorvastatin
10 mg
Other Name: Citalor
Drug: Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Other Name: Hyzaar
Drug: Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Name: Polipílula

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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692717

Contacts
Contact: Alexandre Frederico, physician 55 19 38716399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clínica Pesquisa e Desenvolvimento Ltda Not yet recruiting
Valinhos, São Paulo, Brazil
Contact: Alexandre Frederico, physician    55 19 38716399    alexandre@lalclinica.com.br   
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01692717     History of Changes
Other Study ID Numbers: ALHHYP0512OR-I, Versão 01 28.05.2012
Study First Received: September 21, 2012
Last Updated: September 24, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Hydrochlorothiazide
Losartan
Atorvastatin
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 23, 2014