Pulmonary Arterial Hypertension (PAH)
Conditions
Interventions
T-R-T-R fast group:Under fasting conditions, subjects were orally administered the test formulation (125 mg/1 tablet) in Cycle 1, followed by the reference formulation (125 mg/1 tablet) in Cycle 2, th
R-T-R-T fast group:Under fasting conditions, subjects were orally administered the reference formulation (125 mg/1 tablet) in Cycle 1, followed by the test formulation (125 mg/1 tablet) in Cycle 2, th
T-R-R fed group:Under standardized high-fat meal conditions, subjects were orally administered the test formulation (125 mg/1 tablet) in Cycle 1 , followed by the reference formulation (125 mg/1 table
R-T-R fed group:Under standardized high-fat meal conditions, subjects were orally administered the reference formulation (125 mg/1 tablet) in Cycle 1 , followed by the test formulation (125 mg/1 table
R-R-T fed group:Under standardized high-fat meal conditions, subjects were orally administered the reference formulation (125 mg/1 tablet) in Cycle 1 , followed by the reference formulation (125 mg/1
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Participants must fully understand the trial's purpose, nature, procedures, and potential adverse reactions, voluntarily agree to participate, and sign the informed consent form before the trial begins; 2) Healthy adult male subjects aged 18–65 years (inclusive); 3) Body mass index (BMI) = weight (kg)/height² (m²), with BMI ranging from 19.0 to 26.0 (inclusive), and male subjects must weigh at least 50.0 kg; 4) From signing the informed consent until 3 months after the study’s completion, subjects must have no plans for reproduction and must agree to use effective and appropriate contraceptive measures (both the subject and their partner); 5) Subjects must be able to communicate effectively with the investigators, understand the study requirements, and comply with all trial protocols.
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to bosentan or any excipient component; or individuals with a history of allergic predisposition (e.g., allergy to two or more drugs or foods); 2) Clinically significant diseases or conditions that may interfere with the study, including but not limited to disorders of the nervous, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic, or skeletal systems; or any factors that may compromise subject safety or affect drug absorption, distribution, metabolism, or excretion (e.g., dysphagia); 3) Major surgery within 30 days prior to dosing or planned surgery during the trial; 4) Intolerance to venipuncture or a history of needle/blood phobia; 5) History of drug abuse or use of illicit substances within 6 months prior to dosing; 6) Blood donation (>=200 mL) or significant blood loss, blood transfusion, or use of blood products within 3 months prior to dosing; or plans to donate blood during the trial; 7) Intention to donate sperm from the first dose until 3 months after study completion; 8) Use of any prescription drugs, over-the-counter medications, supplements, or herbal medicines within 14 days prior to dosing; 9) Use of any drugs known to inhibit or induce hepatic drug metabolism (e.g., inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, verapamil, fluoroquinolones, antihistamines) or any other medications (including traditional Chinese medicine) deemed by the investigator to potentially affect the pharmacokinetic evaluation of the study drug within 30 days prior to dosing; 10) Use of any phosphodiesterase-5 (PDE5) inhibitors for erectile dysfunction (e.g., sildenafil citrate, vardenafil hydrochloride, tadalafil) within 30 days prior to dosing; 11) Vaccination within 30 days prior to dosing; 12)Smoking >5 cigarettes per day on average within 30 days prior to screening or inability to abstain from smoking from informed consent until study completion; 13) Alcohol intake exceeding 2 units per day on average (1 unit = 360 mL beer [5% alcohol], 45 mL liquor [40% alcohol], or 150 mL wine [12% alcohol]) within 30 days prior to screening or inability to abstain from alcohol during the study; 14) Excessive consumption of tea, coffee, or caffeine-containing beverages (>8 cups/day, 1 cup = 250 mL) within 30 days prior to screening or inability to abstain from these during the study; 15) Consumption of foods or beverages known to affect drug pharmacokinetics (e.g., pineapple, dragon fruit, mango, grapefruit, lime, star fruit, chocolate, or products containing caffeine, xanthine, or grapefruit) within 48 hours before screening or from informed consent until the first dose; 16) Special dietary requirements, inability to adhere to a standardized diet, or unusual dietary habits (e.g., fasting, low-sodium diet) within 30 days prior to screening; 17) Lactose/galactose intolerance; 18) Participation in another drug or medical device clinical trial with investigational product use within 3 months prior to dosing; 19) Clinically significant abnormalities in vital signs or physical examination; 20) Clinically significant abnormalities in laboratory tests (e.g., hematology, biochemistry, coagulation, urinalysis, transfusion-related tests) or electrocardiogram (ECG) as judged by the investigator; 21) Positive alcohol breath test (>0.0 mg/100 mL); 22) Positive urine drug screen (morphine, methamphetamine, ketamine, MDMA, THC); 23
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, Maximum plasma concentration;AUC0-t, Area under the concentration-time curve from zero to the last measurable concentration;AUC0-8, Area under the concentration-time curve from zero to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Time to peak concentration;?z, Elimination rate constant;t1/2, Terminal elimination half-life;AUC_%Extrap, Percentage of residual area; | — |
Countries
China
Contacts
Public ContactChunhua Zhou
The First Hospital of Hebei Medical University
Outcome results
None listed