Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers

Last updated: June 14, 2023
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

non-somking

Smoking

Clinical Study ID

NCT05126381
2021LCYJ040
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: According to the selection criteria for non-smokers: No previous smoking history;Or previous smokers who had quit smoking for more than 6 monthsprior to enrollment. A smoker joins the queue by:

  1. Have smoked for more than one year (more than one cigarette per day on average andmore than six months continuously) and have not quit at present.
  2. Agree to smoke cigarettes sold in the market according to the requirements of theprogram. Both smokers and non-smokers were forced to meet additional inclusion criteria at the costof a smoker:
  3. Age: 18-70 (boundary value included), no gender limitation;
  4. Patients who meet one of the following conditions: ① Patients who were previously diagnosed with hypertension, were taking levamlodipinebesylate tablets for antihypertensive therapy, and were managed according tohypertensive lifestyle (diet and exercise) for a long time. ② Patients who were previously diagnosed with type 2 diabetes, were taking metforminsustained-release tablets for hypoglycemic treatment, and were managed according todiabetic lifestyle (diet and exercise) for a long time.
  5. Fixed dosing regimen was used one month before enrollment, and the regimen could becontinued after enrollment.
  6. Subjects understand the risks and regulations of the study and can abide by the studyprotocol, voluntarily participate in the study and sign the informed consent.

Exclusion

Exclusion Criteria:

  1. Have a history of alcohol abuse (drinking more than 14 units of alcohol per week, 1unit =350 mL beer or 44 mL 40% alcohol spirits or 150 mL wine) or have a history ofalcohol abuse and have been abstinent for less than 3 months.
  2. The subject has a history of pathophysiological conditions affecting drug absorption (such as inability to swallow, vomiting, diarrhea, etc.) or gastrointestinal surgeryaffecting 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 thisstudy due to safety or compliance factors.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: non-somking
Phase:
Study Start date:
January 13, 2022
Estimated Completion Date:
April 30, 2024

Study Description

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.

Connect with a study center

  • Yu Xian

    Chongqing,
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.