Public health
Conditions
Interventions
Main ingredients of electronic cigarettes: glycerin, propylene glycol, nicotine, fragrance:Free suction
E-cigarette group, cigarette group
:Puff once
Sponsors
Dongguan Kanghua Hospital Phase I Clinical Trial Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Chinese healthy male or female subjects, with an appropriate sex ratio; 2) Able to understand the informed consent form, voluntarily participate and sign the informed consent form; 3) The age at the time of signing the informed consent form is over 18 years old and under 45 years old (including 18 years old and 45 years old); 4) At least 50.0 kg for men and 45.0 kg for women; the body mass index (BMI) of all subjects is between 19.0 ~ 26.0 kg/m2 (including boundary values); 5) Exhaled carbon monoxide (CO) content >= 10 ppm during screening; 6) Urine cotinine test was positive at the time of screening and selection; 7) Screening and inquiring subjects self-reported that they smoked at least 10 cigarettes a day on average, with a length of 83 mm to 100 mm, and had at least 6 months of smoking history before screening (Note: Smokers who use menthol cigarette products are not eligible Research conditions); 8) Only use traditional cigarettes 30 days before screening; 9) Willing to switch from the current cigarette to one of the test products during the hospital; 10) Able to read and fill out questionnaires written in Chinese; 11) Able to complete the experiment in accordance with the research plan. Those who do not meet one of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic to any components in e-cigarettes or e-liquid (such as benzoic acid, propylene glycol, glycerin, etc.); 2) Smokers who have the habit of inhaling smoke into the mouth or throat instead of inhaling the smoke into the lungs; 3) Used cigarettes/nicotine products other than cigarettes within 1 month before screening; 4) Those who have a smoking cessation plan and decide to postpone smoking cessation for participating in this study; 5) Have used any products or supplements that help quit smoking before screening, including but not limited to any nicotine replacement therapy (NRT), short-term bridging therapies (such as nicotine gum, lozenges, patches), varenicline (Chantix), Bupropion or Lobelia; 6) Those who have been exposed to solvent fumes or gasoline for a long time (for example, painters, auto mechanics); 7) The subject or his immediate family members (parents, siblings, children) are current employees, shareholders or board members of Shenzhen Wuxin Technology Co., Ltd., or are employed by clinical research institutions; 8) Part of my job is to deal with e-liquid or unprocessed tobacco; 9) Women older than or equal to 35 years old are currently using systemic, estrogen-containing contraception, or hormone replacement to treat menopausal-related symptoms; 10) People with diabetes, asthma or chronic obstructive pulmonary disease; 11) Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism, and excretion of markers; 12) Diseases with abnormal clinical manifestations that need to be ruled out, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, people with mental disorders, bones and other systems Sick 13) For patients with abnormal vital signs and clinical significance, refer to the normal range (including cut-off values): sitting systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, pulse 60-110 beats/min, body temperature 36.0-37.2 degrees C, The specific situation is comprehensively determined by the researcher; 14) Those who cannot tolerate venipuncture, and those who have a history of fainting needles and bleeding; 15) People who are lactose intolerant (people who have had milk diarrhea); 16) Used drugs within 3 months before screening; 17) Those who have participated in other clinical researches within 3 months before screening or who have participated in clinical researches not in person; 18) Those who donated blood including blood components or massive blood loss (>=400 mL) within 3 months before screening, received blood transfusion or used blood products; 19) The subject has a childbirth plan or sperm donation or egg donation plan within 3 months; 20) Use products known to interact with cytochrome P450 (CYP) 2A6 (including but not limited to amiodarone, amlodipine, amobabital, buprenorphine, clofibrate) within 14 days before screening , Clotrozole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, metsulfonamide, methafen, letrozole, methotrexate, miconazole , Modafinil, Orphenadrine, Pentobarbital, Phenobarbital, Pilocarpine, Primidone, Propoxyphene, Quinidine, Rifampicin, Rifampicin, Secobarbital, Selegiline, Sulconazole, Tioconazole, Trans-cyclopropy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trans-3-hydroxycotinine;Nicotine Glucuronides;Cotinine Glucuronides;NNAL;NNN;3-HMPMA;2-HPMA;3-HPMA;SPMA;HEMA;AAMA;CEMA;WS-23;AUC_%Extrap;AUC0-;AUC0-t;CL;Cmax;CO;bioavailability;NO;t1/2; | — |
Countries
China
Contacts
Public ContactGuoping Zhong
Outcome results
None listed