None
Conditions
Interventions
pilot study nebulized inhalation group:On the day of administration, subjects shall take 1 vial (100 mg/2 mL) of isoniazid injection via nebulizer under fasting conditions
oral administration group:On the administration day, subjects shall take one tablet (0.1 g) of isoniazid tablets orally in a single dose on an empty stomach with 240 mL of water.
nebulized inhalation group:On the day of administration, subjects shall take 1 vial (100 mg/2 mL) of isoniazid injection via nebulizer under fasting conditions.
Sponsors
Wuhan Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The study participant fully understands the purpose, nature, and methods of the trial, as well as the potential adverse reactions, voluntarily agrees to participate in the study, and signs the informed consent form prior to the initiation of any study procedures; 2.Male and female study participants aged 18 years or older, with an appropriate gender ratio; 3.Male participants weigh >=50.0 kg, female participants weigh >=45.0 kg, and have a body mass index (BMI) within the range of 19.00–28.00 kg/m^2 (including the critical values); 4.Participants with normal results, or with abnormalities judged by the investigator to be clinically insignificant, on the following assessments: vital signs (reference ranges: systolic blood pressure 90–139 mmHg, diastolic blood pressure 60–89 mmHg, pulse 55–100 beats per minute, forehead temperature 36.0–37.3 °C (all including boundary values)), physical examination, screening period clinical laboratory tests, pulmonary function tests, chest CT scan, nicotine screening, and other auxiliary examinations; 5.Participants who are identified as rapid acetylators by NAT2 genotyping screening; 6.Participants who are able to communicate effectively with the investigator and who understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1.Use of any investigational product within 1 month prior to receiving the study drug, or participation in any other clinical trial of drugs or medical devices; 2.(Self-reported) History of diseases or severe medical conditions involving the cardiovascular, digestive, genitourinary, respiratory, hematologic, endocrine, immune, or neuropsychiatric systems (e.g., psychosis, epilepsy, peripheral neuropathy or risk thereof), or the musculoskeletal system; in particular, a history of gastrointestinal dysfunction, peptic ulcer disease, gastrointestinal surgery, or other conditions that could affect drug absorption, distribution, metabolism, or excretion; 3.(Self-reported) Use of any prescription or over-the-counter medications, health supplements, or receipt of any vaccine within 2 weeks prior to screening; 4.(Self-reported) History of drug abuse or illicit drug use within 6 months prior to screening; 5.(Self-reported) Smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from all tobacco products during the study; 6.(Self-reported) Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit = 17.7 mL ethanol, equivalent to 357 mL of 5% beer, 43 mL of 40% spirits, or 147 mL of 12% wine), or inability to abstain from alcohol during the study; 7.(Self-reported) History of specific allergies (e.g., asthma, urticaria, eczema), known hypersensitivity to two or more drugs, foods, or pollens, or known allergy to any component of the study drug, ethionamide, pyrazinamide, nicotinic acid, or structurally related compounds, benzodiazepines, or anesthetic agents such as lidocaine; 8.(Self-reported) Donation of blood (including components) or significant blood loss (>=200 mL, excluding menstrual blood loss) within 3 months prior to screening, receipt of blood transfusion or blood products, or plan to donate blood during the study; 9.(Self-reported) Intolerance to venipuncture, or history of vasovagal reactions to needles or blood; 10.(Self-reported) History of psychotropic substance abuse; 11.(Self-reported) Major surgery within 3 months prior to the study, or planned surgery within 3 months after study drug administration; 12.(Self-reported) Special dietary restrictions that would prevent adherence to the standardized study diet; 13.(Self-reported) Plans for pregnancy, or unwillingness/inability to use effective contraception from 2 weeks prior to screening until 3 months after the last dose of study drug; 14.(Self-reported) Female participants who have had unprotected sex within 14 days prior to dosing, or who are pregnant or breastfeeding; 15.(Self-reported) Difficulty swallowing; 16.(Self-reported) Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to screening (e.g., inducers: barbiturates, carbamazepine, phenytoin, corticosteroids, omeprazole; inhibitors: SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 17.(Self-reported) Inability to undergo bronchoalveolar lavage (BAL) or inability to tolerate anesthesia; 18.(Self-reported) Daily consumption of excessive tea, coffee, and/or caffeinated beverages (more than 8 cups per day, where 1 cup = 250 mL); 19.(Self-reported) History of hepatitis, isoniazid-related liver injury, severe adverse reactions to isoniazid (e.g., drug fever, chills, arthritis), or acute liver disease of any etiology; 20.Presence of oral ulcers or o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| isoniazid concentration;the maximum plasma concentration;the areas under the plasma concentration–time curve ;AUC0-8;Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactLiu Guan
Wuhan Pulmonary Hospital
Outcome results
None listed