chronic hepatitis
Conditions
Interventions
Pre-test group:each subject uses 50mg single-dose of kangdaprevir sodium tables
first group(50mg):The first group needed to complete a single-dose clinical study at a dose of 50 mg, enrolled12 subjects, 10 subjects received the kangdaprevir sodium tables,2 sujects received placeb
send group(100mg,food infection):The second group needed to complete a single-dose clinical study at a dose of 100 mg, enrolled22 subjects, 11 subjects assigned to group A, 11 subjects assigned to gro
Third group(200mg,single dose):10 subjects received the kangdaprevir sodium tables,2 sujects received placebo, with a similar male-to-female ratio. Administered 200mg once,
Fouth group(400mg,single dose):10 subjects received the kangdaprevir sodium tables,2 sujects received placebo, with a similar male-to-female ratio. Administered 400mg once,
Fifth group(600mg,single dose):10 subjects received the kangdaprevir sodium tables,2 sujects received placebo, with a similar male-to-female ratio. Administered 600mg once,
Sixth group(800mg,single dose) : 10 subjects received the kangdaprevir sodium tables,2 sujects received placebo, with a similar male-to-female ratio. Administered 800mg once,
Seventh group(100mg,multi-dose):complete a multi-dose clinical study at a dose of 100 mg daily, for five consecutive days. enrolled12 subjects, 10 subjects received the kangdaprevir sodium tables,2 su
Eighth(200mg,multi-dose:complete a multi-dose clinical study at a dose of 100 mg daily, for five consecutive days. enrolled12 subjects, 10 subjects received the kangdaprevir sodium tables,2 sujects re
Ninth(400mg,multi-dose): complete a multi-dose clinical study at a dose of 100 mg daily, for fi
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the study procedure and fully understand the test contents, process and possible adverse reactions; 2) Be able to complete the study according to protocol; 3) Subjects (including partners) are willing to have no pregnancy plan within the next 6 months and are willing to take effective contraceptive measures voluntarily. Specific contraceptive measures are given in appendix; 4) male and female subjects aged 18-45 years (including 18 and 45 years old), Male subjects should have baby; 5) Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg. Body mass index (BMI) = weight (kg) / height 2 (m2), body mass index 18 ~ 28kg / m2 range (including the critical value); 6) Health: no heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic disorders and other medical history; 7) physical examination, vital signs of normal or abnormal clinical significance.
Exclusion criteria
Exclusion criteria: 1) More than 5 cigarettes smoked daily during the past 3 months 2) allergy to study drugs or their excipients, allergies (multiple drugs and food allergies); 3) A history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine); 4) People with positive urinalysis(Such as opioids, barbiturates, benzodiazepines, tricyclic antidepressants, phencyclidine, amphetamines, cannabis, cocaine, etc) or who have had a history of drug abuse or who have used drugs during the past five years; 5) Blood donation or massive blood loss (> 450 mL) during past three months prior to screening or plan to donate blood within 1 month after study completion ; 6)Have difficulty to swallow or have any history of gastrointestinal, liver, kidney diseases that affect drug absorption or excretion; 7) Any condition that increases the risk of hemorrhaging, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 8) Take any medication that changes liver enzyme activity during past 1 month prior to screening; 9) Take any medication that contain P-gp, or BCRP inhibitors or inducers such as itraconazole, Clarithromycin, or dronedarone; 10) Take any drug that inhibit gastric acid secretion within 1 month prior to use study drug. Such as H2 Receptor Antagonist as Cimetidine, ranitidine, famotidine, nizatidine and Roxatidine; proton pump inhibitors as omeprazole, lansoprazole, rabeprazole , pantoprazole, esomeprazole; acetylcholine receptor antagonist as atropine, pirenzepine. 11) Take any Antacid drugs within 1 month prior to use study drug. Such as Sodium bicarbonate, magnesium hydroxide, aluminum hydroxide, calcium carbonate, three magnesium silicate, etc. 12) Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days prior to screening; 13) Those who have taken special diet (including dragon fruit, mango, grapefruit, etc.) or have strenuous exercise or other factors that influence the absorption, distribution, metabolism and excretion of drugs within 2 weeks before screening; 14) Recent changes in diet or exercise habits; 15) Took any study medication or participated any clinical trial within three months before taking the study medication; 16) Subjects who can not tolerate standard meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 70g, 115g fried potato strips, 240 ml whole milk) (This applies only to participants who participated in the postprandial test Of subjects); 17) ECG abnormalities have clinical significance; 18) Female subjects are lactating or have positive pregnancy outcomes during the screening or study procedure; 19) Clinical laboratory tests showed clinically significant abnormalities, or other clinically relevant diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung , Immune, mental or cardiovascular disease); 20) Viral hepatitis (including hepatitis B and C), HIV antibody, Treponema pallidum antibody screening positive. 21) Acute illness or concomitant medication during the phase of screening to using study medicine; 22) Took chocolates, any caffeine or xanthine-rich food or drink within 24 hours prior to taking the study drug; 23) Have taken any alcoholic product within 24 hours prior to taking the study medication; 24) Other conditions that investigator evaluate subjects are not suitable to participate the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance evaluation;30)Single dose PK parameter;Steady state PK parameter; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed