Viral hepatitis
Conditions
Interventions
Case series:HS-10234 25 mg
Sponsors
The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be informed and consent prior to study, and sign a written informed consent form voluntarily; 2. Male or female healthy subjects; Between 18 and 45 years of age, inclusive, similar ages; 3. Body weight should be >=50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive, similar body weights; 4. Men or women who agree to effective contraception during the trial and within three months after the last Administration; 5. Subjects is able to well communicate with investigators and complete the study in compliance with the protocol.
Exclusion criteria
Exclusion criteria: 1) Physical examination, vital signs examination, electrocardiogram or clinical laboratory examination were abnormal and had clinical significance; 2) Subject has/had any history of serious disease, including but not limited to digestive, cardiovascular, respiratory, urinary, musculoskeletal, endorine, nervous, hemotologic, immune system or metabolic disorder; 3) Those who underwent surgery that would affect drug absorption, distribution, metabolism and excretion that were judged unsuitable by the researchers; 4) Those with dysphagia or any history of gastrointestinal disorders affecting drug uptake,and were judged by the researchers to be unsuitable for enrollment; 5) Renal function test: creatinine level > 1.2 *UNL; 6) Those who are prone to allergic reactions (such as rash, eczema, urticaria, asthma, etc.) or allergic to the components or analogues of this drug; 7) Those who taken any prescription, over-the-counter, Chinese herbal medicine or health products (except for external or topical preparations) Within 14 days before taking the research drug; 8) Have taken any drugs that can inhibit or induce hepatic metabolism within 1 month before administration of investigational drug(eg:Inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 9) Those who have participated in other drug clinical trials within the first 3 months; 10) Those with a history of blood donation or acute blood loss in the first 3 months (400 mL); 11) Those who had taken a special diet (e.g. grapefruit) within 7 days before taking the research drug; 12) Those who have taken any alcoholic products or have positive alcohol screening within 24h before taking the research drug; 13) Those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) daily, within 30d before screening; 14) Smokers or those who smoked more than five cigarettes a day in the first three months of screening ; 15) For alcoholics or regular drinkers within 6 months before screening, they drank more than 14 units of alcohol per week (1 unit = 285 ml beer or 25 mL spirits or 100 mL wine); 16) Those who was a history of drug abuse or drug users within 5 years before screening; 17) Female subjects were breast-feeding or pregnancy positive during screening or clinical trials 18) Those who got new diseases Pre-study screening or pre-medication screening; 19) Those who have special dietary requirements and are unable to comply with the unified diet; 20) Intolerant of venipuncture; 21) Subjects may not be able to complete this study for other reasons, or the researchers may judge unsuitable participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactJIAN LIU
The First Affiliated Hospital, Zhejiang University
Outcome results
None listed