Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Drug plasma steady state concentrations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the selection criteria for non-smokers:
- •No previous smoking history;Or previous smokers who had quit smoking for more than 6 months prior to enrollment.
- •A smoker joins the queue by:
- •Have smoked for more than one year (more than one cigarette per day on average and more than six months continuously) and have not quit at present.
- •Agree to smoke cigarettes sold in the market according to the requirements of the program.
- •Both smokers and non-smokers were forced to meet additional inclusion criteria at the cost of a smoker:
- •Age: 18-70 (boundary value included), no gender limitation;
- •Patients who meet one of the following conditions:
- •① Patients who were previously diagnosed with hypertension, were taking levamlodipine besylate tablets for antihypertensive therapy, and were managed according to hypertensive lifestyle (diet and exercise) for a long time.
- •② Patients who were previously diagnosed with type 2 diabetes, were taking metformin sustained-release tablets for hypoglycemic treatment, and were managed according to diabetic lifestyle (diet and exercise) for a long time.
- •Fixed dosing regimen was used one month before enrollment, and the regimen could be continued after enrollment.
- •Subjects understand the risks and regulations of the study and can abide by the study protocol, voluntarily participate in the study and sign the informed consent.
排除标准
- •Have a history of alcohol abuse (drinking more than 14 units of alcohol per week, 1 unit =350 mL beer or 44 mL 40% alcohol spirits or 150 mL wine) or have a history of alcohol abuse and have been abstinent for less than 3 months.
- •The subject has a history of pathophysiological conditions affecting drug absorption (such as inability to swallow, vomiting, diarrhea, etc.) or gastrointestinal surgery affecting drug absorption.
- •HBsAg, HCV or syphilis antibody tested positive in the past.
- •Pregnant and lactating women.
- •The investigator considers that the subjects are not suitable to participate in this study due to safety or compliance factors.
结局指标
主要结局
Drug plasma steady state concentrations
时间窗: Blood samples were collected 30 minutes before administration
drug plasma steady state concentrations are regard as the PK parameters
次要结局
未报告次要终点