Phase
Condition
Hepatitis B
Treatment
N/AClinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the informed consent before the trial and fully understand the content, processand possible adverse reactions of the trial;
Ability to complete research in accordance with test plan requirements;
Subjects (including partners) are willing to take effective pregnancy avoidancemeasures within 6 months after screening to the last study drug administration;
Male and female healthy subjects aged 18 to 55 years (including 18 and 55 years old);
Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg.Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in therange of 18 ~ 28 kg / m2 (including critical value);
Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion
Exclusion Criteria:
Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
Allergies (multiple drugs and food allergies);
Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
Blood donation or massive blood loss (> 450 mL) within three months before screening;
Take any drug that changes the activity of liver enzymes 28 days before screening;
Took any prescription drugs, over-the-counter drugs, any vitamin products, or herbswithin 14 days before screening;
Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.)or have vigorous exercise or other factors affecting drug absorption, distribution,metabolism, excretion, etc. within 2 weeks before screening;
Combined with inhibitors or inducers of CYP3A4, such as itraconazole, ketoconazole,etc.;
Major changes in diet or exercise habits recently;
Have taken the study drug or participated in the drug clinical trial within threemonths before taking the study drug;
Have a history of dysphagia or any gastrointestinal disease that affects drugabsorption;
Have any disease that increases the risk of bleeding, such as hemorrhoids, acutegastritis, or gastric and duodenal ulcers;
Subjects who cannot tolerate a standard meal (two boiled eggs, a piece of butteredbacon toast, a box of fried potato strips, a cup of full-fat milk) (this strip is onlyapplicable to subjects participating in post-meal trials);
Abnormal ECG has clinical significance;
Female subjects were breastfeeding during the screening period or during the trial orwere preparing for pregnancy recently or had a positive serum pregnancy result;
Clinical laboratory examinations are abnormal and clinically significant, or thefollowing diseases (including but not limited to gastrointestinal tract, kidney,liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovasculardisease);
Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen /antibody, and Treponema pallidum antibody;
Acute disease or concomitant medication occurs from the screening stage to beforestudy medication;
Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours beforetaking the study drug;
Have taken any alcohol-containing product within 24 hours before taking the studydrug;
People who have a positive urine drug screen or have a history of drug abuse or haveused drugs within the past five years;
The investigator believes that there are other subjects who are not suitable forparticipating in this trial.
Study Design
Study Description
Connect with a study center
The first hospital of Jilin University
Changchun, Jilin 130000
ChinaActive - Recruiting
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