Purpose of study: Establishing population pharmacokinetic - pharmacodynamic models of chronic disease therapeutics for smoking patients to investigate the effects of gender, age, body weight, liver function, kidney function, nicotine, polycyclic aromatic hydrocarbon related metabolic enzymes and drug related metabolic enzymes gene polymorphism on steady-state drug concentration and efficacy in chronic smoking patients after taking drugs. Object of study: Smoking and non-smoking patients taking levamlodipine besylate tablets or metformin sustained-release tablets.
Purpose of study: Establishing population pharmacokinetic - pharmacodynamic modes of chronic disease therapeutics for smoking patients to investigate the effects of gender, age, body weight, liver function, kidney function, nicotine, polycyclic aromatic hydrocarbon related metabolic enzymes and drug related metabolic enzymes gene polymorphism on steady-state drug concentration and efficacy in chronic smoking patients after taking drugs. Object of study: Smoking and non-smoking patients taking Levamlodipine besylate tablets or metformin sustained-release tablets. Parameters of study: PK parameters: drug plasma concentration. PD parameters: blood pressure or blood sugar. covariates: Gender, age, height, weight, BMI, liver function (ALT, AST, TP, TBIL), kidney function (Scr, UA, UREA), nicotine plasma concentration, cigarette related metabolic enzyme gene (CYP1A1, CYP1A2) polymorphism and drug-related metabolic enzyme gene (CYP3A4, CYP3A5, MATE1), MARE2, OCT2) polymorphism, etc. Safety : adverse events occurred during the test.
Study Type
OBSERVATIONAL
Enrollment
200
The Study contains patients who are allowed to smoke
The Study contains patients who are not allowed to smoke
Yu Xian
Chongqing, China
RECRUITINGDrug plasma steady state concentrations
drug plasma steady state concentrations are regard as the PK parameters
Time frame: Blood samples were collected 30 minutes before administration
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