Study on PK of Hydronidone in Patients and Special Population (NCT04123769) | Clinical Trial Compass
CompletedPhase 1
Study on PK of Hydronidone in Patients and Special Population
China8 participantsStarted 2019-09-03
Plain-language summary
1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction).
2. To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Scores assessed by child-pugh system are 5 or 6;
Exclusion criteria
✕. Those who do not meet any of the inclusion criteria;
✕. (consultation) participants in clinical trials of other drugs in recent 3 months;
✕. (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoximate, griseofulvin, aminopropyl ester, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);
✕. (consultation) select those who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =250mL) every day during the first three months; Or from the screening to -1 days after admission, intake of any food or drink containing caffeine and xanthine (such as coffee, strong tea, chocolate, etc.) and other special diet that affects the absorption, distribution, metabolism and excretion of drugs;
✕. (consultation) patients who had taken food or drinks containing enzymes that can induce or inhibit liver metabolism (e.g., grapefruit, mango, pitaya, grape juice, orange juice and other compounds rich in flavonoids or citrus glycosides) before admission were screened.
✕. (consultation) screening: drinking more than 14 standard units of alcohol per week in the first 3 months (1 standard unit contains 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or cannot abstain from alcohol during the test period; Or taking any alcohol products within 24 hours before the first dose of the study;
✕. (consultation) select those who smoke more than 5 cigarettes per day within the first 3 months, or cannot stop using any tobacco products during the trial; Screening for smoking or using any tobacco products up to admission;
✕. (consultation) previous history of drug abuse and drug abuse;