Clinical Assessment Of Association Pharmacokinetics Atorvastatin + Losartana + Hydrochlorothiazide Produced By Lab Hypermarcas S/A In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirm voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
- •Age between 18 and 55 years, regardless of sex, clinically healthy and present laboratory parameters within normal limits;
- •BMI ≥ 18.5 and ≤ 30.
排除标准
- •Participation in clinical trials in the 12 months preceding the survey;
- •History of hypersensitivity reactions to atorvastatin, losartan hydrochlorothiazide and / or any other ingredients of medicines;
- •Alterations in clinical and laboratory criteria that interfere Principal Investigator on the study results;
- •Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
- •Acute illness during the 07 days preceding the start of the study;
- •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);
- •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.
- •Use of medications that interact with any medications association;
- •History of or current use for at least 12 months of tobacco;
- •Current or previous history (under 12 months) of illicit drug use;
- •At the discretion of the Principal Investigator of the study.
研究组 & 干预措施
Atorvastatin
Citalor (Atorvastatin) - Pfizer
干预措施: Atorvastatin (Drug)
Atorvastatin
Citalor (Atorvastatin) - Pfizer
干预措施: Hydrochlorothiazide + Losartan (Drug)
Atorvastatin
Citalor (Atorvastatin) - Pfizer
干预措施: Hydrochlorothiazide + Losartan + Atorvastatin (Drug)
Hydrochlorothiazide + Losartan
Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
干预措施: Atorvastatin (Drug)
Hydrochlorothiazide + Losartan
Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
干预措施: Hydrochlorothiazide + Losartan (Drug)
Hydrochlorothiazide + Losartan
Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme
干预措施: Hydrochlorothiazide + Losartan + Atorvastatin (Drug)
Atorvastatin + Hydrochlorothiazide + Losartan
Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
干预措施: Atorvastatin (Drug)
Atorvastatin + Hydrochlorothiazide + Losartan
Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
干预措施: Hydrochlorothiazide + Losartan (Drug)
Atorvastatin + Hydrochlorothiazide + Losartan
Polipílula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas
干预措施: Hydrochlorothiazide + Losartan + Atorvastatin (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)