RBR-6p37zr已完成4 期

Evaluation of the effect of systemic lupus erythematosus on the activity of the OATP1B1 transporter using atorvastatin PK-PD.

Faculdade de Ciências Farmacêuticas de Ribeirão Preto da Universidade de São Paulo0 个研究点开始时间: 2020年1月27日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Healthy Volunteers Group: no active chronic kidney disease; no clinical and laboratory evidence of inflammation; no diagnosis of lupus; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).
•Uncontrolled SLE Patients Group: SLEDAI scores between 6 and 12; no active chronic kidney disease; with clinical and laboratory evidence of inflammation; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).
•Controlled SLE patients group: SLEDAI scores between 0 and 5; no active chronic kidney disease; with clinical and laboratory evidence of inflammation; age between 18 and 40 years; BMI less than 30 kg / m2; women; normal liver function (birubins, AST, ALT and Gamma-GT); normal renal function (serum urea and creatinine dosage).

•History of severe chronic obstructive pulmonary disease; healthy patients or volunteers treated with MDR1, OATP1B1 and CYP3A inducers or inhibitors.

发起方

Faculdade de Ciências Farmacêuticas de Ribeirão Preto da Universidade de São Paulo