HBV
Conditions
Interventions
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), body mass index in the range of 18 ~ 28kg/m2 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination, vital signs normal or abnormal no clinical significance.;Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), body mass index in the range of 18 ~ 28kg/m2 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination, vital signs normal or abnormal no clinical significance.;Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), body mass index in the range of 18 ~ 28kg/m2 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination, vital signs normal or abnormal no clinical significance.;Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), body mass index in the range of 18 ~ 28kg/m2 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination, vital signs normal or abnormal no clinical significance.;Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg)/height 2 (m2), body mass index in the range of 18 ~ 28kg/m2 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination, vital signs normal or abnormal no clinical significance.
Exclusion criteria
Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial; 2) allergic history of allergenic and allergy (a variety of drugs and food allergy) to tebufloxate allylamine hemi-fumarate tablets or their excipients; 3) History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 7) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 8) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9) There have been significant changes in diet or exercise habits recently; 10) took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 11) have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs. 12) suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) ECG abnormalities have clinical significance; 14) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15) Clinical laboratory examination has clinical significance; 16) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 17) in the pre-study screening stage or before the study of acute disease; 18) Take up to chocolate, any caffeine-containing food or drink 48 hours before taking the study drug; 19) took any alcoholic products within 48 hours prior to taking the study; 20) alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial. 21) Subjects who can not tolerate high-fat meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) (this article only applies to participating meals Post-test subjects).;Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial; 2) allergic history of allergenic and allergy (a variety of drugs and food allergy) to tebufloxate allylamine hemi-fumarate tablets or their excipients; 3) History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 7) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 8) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9) There have been significant changes in diet or exercise habits recently; 10) took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 11) have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs. 12) suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) ECG abnormalities have clinical significance; 14) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15) Clinical laboratory examination has clinical significance; 16) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 17) in the pre-study screening stage or before the study of acute disease; 18) Take up to chocolate, any caffeine-containing food or drink 48 hours before taking the study drug; 19) took any alcoholic products within 48 hours prior to taking the study; 20) alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial. 21) Subjects who can not tolerate high-fat meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) (this article only applies to participating meals Post-test subjects).;Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial; 2) allergic history of allergenic and allergy (a variety of drugs and food allergy) to tebufloxate allylamine hemi-fumarate tablets or their excipients; 3) History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 7) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 8) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9) There have been significant changes in diet or exercise habits recently; 10) took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 11) have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs. 12) suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) ECG abnormalities have clinical significance; 14) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15) Clinical laboratory examination has clinical significance; 16) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 17) in the pre-study screening stage or before the study of acute disease; 18) Take up to chocolate, any caffeine-containing food or drink 48 hours before taking the study drug; 19) took any alcoholic products within 48 hours prior to taking the study; 20) alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial. 21) Subjects who can not tolerate high-fat meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) (this article only applies to participating meals Post-test subjects).;Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial; 2) allergic history of allergenic and allergy (a variety of drugs and food allergy) to tebufloxate allylamine hemi-fumarate tablets or their excipients; 3) History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 7) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 8) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9) There have been significant changes in diet or exercise habits recently; 10) took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 11) have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs. 12) suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) ECG abnormalities have clinical significance; 14) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15) Clinical laboratory examination has clinical significance; 16) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 17) in the pre-study screening stage or before the study of acute disease; 18) Take up to chocolate, any caffeine-containing food or drink 48 hours before taking the study drug; 19) took any alcoholic products within 48 hours prior to taking the study; 20) alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial. 21) Subjects who can not tolerate high-fat meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) (this article only applies to participating meals Post-test subjects).;Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial; 2) allergic history of allergenic and allergy (a variety of drugs and food allergy) to tebufloxate allylamine hemi-fumarate tablets or their excipients; 3) History of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 ml of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) Take any drug that changes liver enzyme activity 28 days before taking the study drug; 6) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 7) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 8) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9) There have been significant changes in diet or exercise habits recently; 10) took the research drug within three months before taking the study medication, or participated in the drug clinical trial; 11) have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs. 12) suffer from any disease that increases the risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 13) ECG abnormalities have clinical significance; 14) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 15) Clinical laboratory examination has clinical significance; 16) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 17) in the pre-study screening stage or before the study of acute disease; 18) Take up to chocolate, any caffeine-containing food or drink 48 hours before taking the study drug; 19) took any alcoholic products within 48 hours prior to taking the study; 20) alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial. 21) Subjects who can not tolerate high-fat meals (2 boiled eggs 100g, 20g bacon, 1 butter toast 50g, 115g fried potato strips, 240ml whole milk) (this article only applies to participating meals Post-test subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYanhua Ding;Yanhua Ding;Yanhua Ding;Yanhua Ding;Yanhua Ding ;;;;
The First Hospital of Jilin University;The First Hospital of Jilin University;The First Hospital of Jilin University;The First Hospital of Jilin University;The First Hospital of Jilin University
Outcome results
None listed