Trials / Unknown
UnknownNCT05126381
Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Smoking | The Study contains patients who are allowed to smoke |
| BEHAVIORAL | non-somking | The Study contains patients who are not allowed to smoke |
Timeline
- Start date
- 2022-01-13
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
- First posted
- 2021-11-19
- Last updated
- 2023-06-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05126381. Inclusion in this directory is not an endorsement.