Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers

NCT05126381 | Unknown

• 1 other identifier: 2021LCYJ040
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Disease; Smoking

Keywords

Population Pharmacokinetics/ Pharmacodynamics; Gene polymorphism; Smoking

Outcome Measures

Primary Outcomes (1)

• Drug plasma steady state concentrations

  drug plasma steady state concentrations are regard as the PK parameters

  Blood samples were collected 30 minutes before administration

Other Outcomes (2)

• Blood pressure levels

  Blood pressure levels were collected 30 minutes before administration

• Blood glucose levels

  Blood glucose levels were collected 30 minutes before administration

Study Arms (4)

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

Smoking BEHAVIORAL

The Study contains patients who are allowed to smoke

Smoker with taking levamlodipine besylate tablets; Smoker with taking metformin sustained-release tablets

non-somking BEHAVIORAL

The Study contains patients who are not allowed to smoke

Non-smoker with taking levamlodipine besylate tablets; Non-smoker with taking metformin sustained-release tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were mainly selected for outpatient follow-up

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Yu Xian

Chongqing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Chronic Disease; Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Yu Xian

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Xian

CONTACT

18512356862; 1clinicaltrial@hospital.cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 19, 2021
• Study Start: January 13, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)