An observational study in Chronic Disease and Smoking, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational
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.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's planned enrollment of 200 is below the median of 419 across 249 observational studies indexed under Chronic Disease.
Browse Chronic Disease studies →The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 98 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects were mainly selected for outpatient follow-up
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:
Both smokers and non-smokers were forced to meet additional inclusion criteria at the cost of a smoker:
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.
Exclusion Criteria:
The subjects are allowed to smoke during the time taking levamlodipine besylate tablets.
Behavioral: Smoking
The subjects are not allowed to smoke during the time taking levamlodipine besylate tablets.
Behavioral: non-somking
The subjects are allowed to smoke during the time taking metformin sustained-release tablets。
Behavioral: Smoking
The subjects are not allowed to smoke during the time taking metformin sustained-release tablets.
Behavioral: non-somking
The Study contains patients who are allowed to smoke
The Study contains patients who are not allowed to smoke
Drug 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
Blood pressure levels
Blood pressure levels are regard as the PD parameters
Time frame: Blood pressure levels were collected 30 minutes before administration
Blood glucose levels
Blood glucose levels are regard as the PD parameters
Time frame: Blood glucose levels were collected 30 minutes before administration
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Chongqing Medical University