Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide
NCT ID: NCT01692717
Last Updated: 2022-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2013-02-28
2013-05-31
Brief Summary
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Detailed Description
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* O-hydroxy atorvastatin (2-Hydroxy atorvastatin, O-HAT): metabolite of AT
* carboxylic acid (E-3174, LS-CA): active metabolite of LS
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Atorvastatin
Citalor (Atorvastatin) - Pfizer
Atorvastatin
10 mg
Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Hydrochlorothiazide + Losartan
Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp \& Dohme
Atorvastatin
10 mg
Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Atorvastatin + Hydrochlorothiazide + Losartan
Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
Atorvastatin
10 mg
Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Interventions
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Atorvastatin
10 mg
Hydrochlorothiazide + Losartan
12.5 mg + 50 mg
Hydrochlorothiazide + Losartan + Atorvastatin
12.5 mg + 50 mg + 10 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Azidus Brasil
INDUSTRY
Responsible Party
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Locations
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LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
Countries
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Other Identifiers
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Version 01 May 28, 2012
Identifier Type: OTHER
Identifier Source: secondary_id
ALHHYP0512OR-I
Identifier Type: -
Identifier Source: org_study_id
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