About this trial
Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subjects, both male and female;
Age: 18-45 years;
Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)/height² (m²));
Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;
Disqualifiers
(Inquiry) Participation in any other clinical trial within three months prior to this study;
(Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders [particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.];
(Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;
(Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);
Trial design
Parallel
Treatments tested in this trial
Hydronidone capsules
DrugSAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs
Placebo capsules
DrugSAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs
Treatment groups
13
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
SAD :Blood drug PK parameters(Cmax)
SAD:Blood drug PK parameters(Tmax)
SAD:Blood drug PK parameters(AUC0-t)
SAD:Blood drug PK parameters( t1/2)
Secondary outcomes
Hydronidone and its metabolites M3 and M4 blood drug concentrations (SAD)
Hydronidone and its metabolites M3 and M4 blood drug concentrations (MAD)
Safety indicator: Any adverse event
Adverse Event (AE) is defined as any untoward medical occurrence during drug clinical trials, drug therapy, or medical procedures, regardless of its causal relationship to the drug used.
Safety indicators:Chest X-ray examination
Sponsors and contacts
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Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
This trial is not recruiting at the moment. You can still explore other options: