Chronic DiseaseNCT05126381
Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers
An observational study of Chronic Disease and Smoking, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Disease, Smoking
- What is being tested?
- Smoking and non-somking
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were mainly selected for outpatient follow-up
Who may be able to join
- 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.
- Both smokers and non-smokers were forced to meet additional inclusion criteria at the cost of a smoker:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu Xian
Chongqing
Yu Xian, Doctor, 18512356862, 1clinicaltrial@hospital.cqmu.edu.cn
Li Guoxing
About this study
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.
- Conditions
- Chronic Disease, Smoking
- Being tested
- Smoking, non-somking
- Keywords
- Population Pharmacokinetics/ Pharmacodynamics, Gene polymorphism, Smoking
- Medical subject headings
- Chronic Disease, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokingBehavioural
The Study contains patients who are allowed to smoke
non-somkingBehavioural
The Study contains patients who are not allowed to smoke
| Study group | Role | What they receive |
|---|---|---|
| Smoker with taking levamlodipine besylate tablets | The subjects are allowed to smoke during the time taking levamlodipine besylate tablets. Receives: Behavioral: Smoking | |
| Non-smoker with taking levamlodipine besylate tablets | The subjects are not allowed to smoke during the time taking levamlodipine besylate tablets. Receives: Behavioral: non-somking | |
| Smoker with taking metformin sustained-release tablets | The subjects are allowed to smoke during the time taking metformin sustained-release tablets。 Receives: 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. Receives: Behavioral: non-somking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug plasma steady state concentrations
drug plasma steady state concentrations are regard as the PK parameters
Measured: Blood samples were collected 30 minutes before administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start13 Jan 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Xian, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126381
- Sponsor's protocol ID
- 2021LCYJ040
- Status last verified
- Dec 2022
- First submitted
- 2 Nov 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers
- ClinicalTrials.gov ID
- NCT05126381
- Acronym / sponsor ID
- 2021LCYJ040
- Conditions
- Chronic Disease, Smoking
- Keywords
- Population Pharmacokinetics/ Pharmacodynamics, Gene polymorphism, Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Smoker with taking levamlodipine besylate tablets | – | Behavioral: SmokingThe subjects are allowed to smoke during the time taking levamlodipine besylate tablets. |
| Non-smoker with taking levamlodipine besylate tablets | – | Behavioral: non-somkingThe subjects are not allowed to smoke during the time taking levamlodipine besylate tablets. |
| Smoker with taking metformin sustained-release tablets | – | Behavioral: SmokingThe subjects are allowed to smoke during the time taking metformin sustained-release tablets。 |
| Non-smoker with taking metformin sustained-release tablets | – | Behavioral: non-somkingThe subjects are not allowed to smoke during the time taking metformin sustained-release tablets. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were mainly selected for outpatient follow-up
Key inclusion criteria (12 listed)
- No previous smoking history;Or previous smokers who had quit smoking for more than 6 months prior to enrollment.
- 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.
- Both smokers and non-smokers were forced to meet additional inclusion criteria at the cost of a smoker:
- Age: 18-70 (boundary value included), no gender limitation;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmokingThe Study contains patients who are allowed to smoke | Behavioural | Smoker with taking levamlodipine besylate tablets, Smoker with taking metformin sustained-release tablets |
| non-somkingThe Study contains patients who are not allowed to smoke | Behavioural | Non-smoker with taking levamlodipine besylate tablets, Non-smoker with taking metformin sustained-release tablets |
Primary outcome
Drug plasma steady state concentrations
Time frame: Blood samples were collected 30 minutes before administration
drug plasma steady state concentrations are regard as the PK parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Xian principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Smoking, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Xian (18512356862, 1clinicaltrial@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug plasma steady state concentrations (time frame: Blood samples were collected 30 minutes before administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.