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Status unknownNCT05126381Updated Jun 18, 2023

Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers

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

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Chronic Disease
  • Smoking

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Keywords

  • Population Pharmacokinetics/ Pharmacodynamics
  • Gene polymorphism
  • Smoking
03

In context

Chronic Disease

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects were mainly selected for outpatient follow-up

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 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.

Both smokers and non-smokers were forced to meet additional inclusion criteria at the cost of a smoker:

  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

Exclusion Criteria:

  1. 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.
  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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Smoker with taking levamlodipine besylate tablets

    The subjects are allowed to smoke during the time taking levamlodipine besylate tablets.

    Behavioral: Smoking

  • Non-smoker with taking levamlodipine besylate tablets

    The subjects are not allowed to smoke during the time taking levamlodipine besylate tablets.

    Behavioral: non-somking

  • Smoker with taking metformin sustained-release tablets

    The subjects are allowed to smoke during the time taking metformin sustained-release tablets。

    Behavioral: Smoking

  • Non-smoker with taking metformin sustained-release tablets

    The subjects are not allowed to smoke during the time taking metformin sustained-release tablets.

    Behavioral: non-somking

Interventions

  • BehavioralSmoking

    The Study contains patients who are allowed to smoke

  • Behavioralnon-somking

    The Study contains patients who are not allowed to smoke

06

What researchers measure

Primary outcomes

  1. 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

Other outcomes

  1. Blood pressure levels

    Blood pressure levels are regard as the PD parameters

    Time frame: Blood pressure levels were collected 30 minutes before administration

  2. Blood glucose levels

    Blood glucose levels are regard as the PD parameters

    Time frame: Blood glucose levels were collected 30 minutes before administration

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05126381
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Responsible party
Sponsor
First posted
Nov 19, 2021
Start date
Jan 13, 2022
Primary completion
Apr 30, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Jun 18, 2023

Study contacts

Yu Xian
Contact
1clinicaltrial@hospital.cqmu.edu.cn
18512356862
Yu Xian
principal investigator · The Second Affiliated Hospital of Chongqing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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