Multidrug-resistant pulmonary tuberculosis
Conditions
Interventions
Group I (fasting T-R):Cycle 1: single oral dose of subject formulation (T, 0.1 g) in fasted state
Cycle 2: single oral dose of reference formulation (R, 100 mg) in fasted state
Group II (fasting R-T):Cycle 1: single oral dose of reference formulation (R, 100 mg) in fasted state
Cycle 2: single oral dose of subject formulation (T, 0.1 g) in fasted state
Group I (postprandial T-R):Cycle 1: Single oral dose of subject formulation (T, 0.1 g) 30 minutes after a standard high-fat, high-calorie breakfast
Cycle 2: Single oral dose of reference formulation
Group II (postprandial R-T):Cycle 1: single oral dose of reference formulation (R, 100 mg) 30 minutes after standard high-fat, high-calorie breakfast
Cycle 2: single oral dose of subject formulation
Sponsors
The First People's Hospital of Hangzhou
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers (male or female) aged >= 18 years; 2. Body weight >= 50 kg for males and >= 45 kg for females; BMI within 19.0–26.0 kg/m²; 3. Ability to fully comprehend the study content and provide written informed consent; 4. Capability to communicate effectively with investigators and comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. (Inquire about) past or current suffering from any clinically serious disease of circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric, or metabolic abnormalities, or any other disease that can interfere with the test results (e.g., hepatic insufficiency, tip-twisting ventricular tachycardia, congenital long QT syndrome, hypothyroidism, bradyarrhythmias, decompensated heart failure, gastrointestinal ulcers, gastrointestinal bleeding, severe bleeding tendency, etc.); and compensated heart failure, gastrointestinal ulcer, gastrointestinal bleeding, severe bleeding tendency, etc.); 2. (Ask) Those with lactose intolerance (e.g., diarrhea after drinking milk); 3. (ask for advice) Those who have a need to drive or operate machinery during the trial; 4. (Ask for advice) Persons with a history of allergy to drugs, food or other substances, or allergy to any of the ingredients in this product; 5. (Ask for advice) who have undergone surgery within 28 days prior to the first dose of study drug, or who plan to have surgery during the trial; 6. (Ask) Anyone who has used any medications or supplements (including herbal remedies) within 14 days prior to taking the study drug for the first time; 7. Those who have used any clinical trial drug or enrolled in any drug/medical device clinical trial within 3 months prior to the first dose of study drug; 8. (Inquire) who have donated blood within 3 months prior to the first dose of study drug, or who have lost more than 400 mL of blood within 3 months prior to the first dose of study drug; 9. (Q&A) Those who cannot tolerate venipuncture and/or have a history of blood or needle sickness; 10. (Ask for consultation) who have used oral contraceptives within 30 days prior to the first dose of study drug or who have used long-acting estrogen or progestin injections or implants within 6 months prior to the first dose of study drug; 11. (Ask) A person (female) who has had unprotected sex within 14 days prior to the first dose of study drug, or a woman who is pregnant or breastfeeding; 12. (Ask for consultation) who are unable to use 1 or more non-pharmacological contraceptives during the trial, or who are planning to have a baby or donate sperm/eggs within 6 months of the end of the trial; 13. (Ask for consultation) Those who have special dietary requirements and cannot comply with the uniform diet; 14. (Ask for consultation) Those who have difficulty in swallowing; 15. (Ask for consultation) who have consumed excessive amounts of tea, coffee or caffeinated beverages (8 or more cups, 1 cup = 250 mL) per day within 3 months prior to the first dose of study drug; 16. (Q&A) Anyone who has ingested or plans to ingest any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) or foods (e.g., sardines, animal liver, etc.) or beverages that are rich in xanthine components within 48 hours prior to the first dose of study drug; 17. (Ask) Anyone who has ingested or plans to ingest grapefruit or grapefruit-related citrus fruits (e.g., limes, grapefruit), poppies, papayas, pomegranates, or products of the above fruits within 14 days prior to the first dose of study drug; 18. (Asked) Smokers who are addicted to tobacco or who have smoked more than 5 cigarettes per day in the 3 months prior to the first dose of study drug; 19. (ASK) Alcoholics or those who consumed alcohol regularly within 6 months prior to the first dose of study drug, i.e., more th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum blood drug concentration;Tmax (time to reach peak);AUC0–72h (area under the blood concentration-time curve from 0 to 72 hours after administration); | — |
Secondary
| Measure | Time frame |
|---|---|
| ?z (terminal elimination rate constant); | — |
Countries
China
Contacts
Public ContactWang Ying
The First People's Hospital of Hangzhou
Outcome results
None listed