Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers
NCT ID: NCT05126381
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-01-13
2024-04-30
Brief Summary
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Object of study: Smoking and non-smoking patients taking levamlodipine besylate tablets or metformin sustained-release tablets.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Smoker with taking levamlodipine besylate tablets
The subjects are allowed to smoke during the time taking levamlodipine besylate tablets.
Smoking
The Study contains patients who are allowed to smoke
Non-smoker with taking levamlodipine besylate tablets
The subjects are not allowed to smoke during the time taking levamlodipine besylate tablets.
non-somking
The Study contains patients who are not allowed to smoke
Smoker with taking metformin sustained-release tablets
The subjects are allowed to smoke during the time taking metformin sustained-release tablets。
Smoking
The Study contains patients who are allowed to smoke
Non-smoker with taking metformin sustained-release tablets
The subjects are not allowed to smoke during the time taking metformin sustained-release tablets.
non-somking
The Study contains patients who are not allowed to smoke
Interventions
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Smoking
The Study contains patients who are allowed to smoke
non-somking
The Study contains patients who are not allowed to smoke
Eligibility Criteria
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Inclusion Criteria
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:
1. 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.
2. Agree to smoke cigarettes sold in the market according to the requirements of the program.
1. Age: 18-70 (boundary value included), no gender limitation;
2. 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.
3. Fixed dosing regimen was used one month before enrollment, and the regimen could be continued after enrollment.
4. 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.
Exclusion Criteria
2. 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.
3. HBsAg, HCV or syphilis antibody tested positive in the past.
4. Pregnant and lactating women.
5. The investigator considers that the subjects are not suitable to participate in this study due to safety or compliance factors.
18 Years
70 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Principal Investigators
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Yu Xian
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Locations
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Yu Xian
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021LCYJ040
Identifier Type: -
Identifier Source: org_study_id
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