Pharmacokinetics and coefficient of variation in human body
Conditions
Interventions
Fasting group I :First cycle: tested agent a
second cycle: tested agent B
third cycle: tested agent C
Fasting group II :First cycle: tested agent B
second cycle: tested agent C
third cycle: tested agent a
Fasting group III :First cycle: tested agent C
second cycle: tested agent a
third cycle: tested agent B
Sponsors
Wuhan Xiangfang Clinical Pharmacology Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers; 2. Aged 18-50 years old; 3. Gender: appropriate proportion of men and women 4. Body weight: not less than 50kg for men and 45kg for women; body mass index [= weight kg / (height m) 2] between 19 and 27 (including boundary value); 5. General physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, coagulation function, urine routine, blood HCG / urine pregnancy (female)) and ECG were normal; 6. systolic blood pressure 90mmhg to 140mmHg, diastolic blood pressure 60mmhg to 90mmHg, subjects with normal blood pressure; 7. Subjects with fev1.0/fvc% of pulmonary air volume not less than 80%; 8. Those who voluntarily participate in the test and are willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects who smoked more than 5 cigarettes per day in the three months before the test; 2. Those who have allergic history or constitution to indadatro, glulammonium bromide or their analogues or their auxiliary materials (multiple drugs and food allergies); 3. Subjects with a history of drug abuse and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285ml of beer, or 25ml of spirits, or 100ml of wine); 4. Blood donation or massive blood loss (> 450 ml) within three months before screening; 5. Patients with dysphagia or any gastrointestinal disease history affecting drug absorption; 6. Patients with any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcer; 7. Subjects who took any drugs that changed the activity of liver enzyme 28 days before screening; 8. Subjects who have taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 14 days before screening; 9. The subjects who had taken special diet (such as grapefruit) or had strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before screening; 10. The subjects who received the following treatment within 7 days before screening: the drugs known to be strong inhibitors of CYP3A4 (i.e. ampinavir, azanavir, boprevir, clarithromycin, conavastatin, dilaviridine, diltiazem, erythromycin, furzanavir, indanavir, itraconazole, ketoconazole, lopinavir, miberadil, miconazole, nefazodone, nefinavir Posaconazole, ritonavir, xaquinavir, tirarevir, telithromycin, verapamil, voriconazole); drugs known to be powerful inducers of CYP3A4 (i.e. carbamazepine, felminate, nevirapine, phenobarbital, phenytoin, promethone, rifampicin, rifampicin, rifapentine and St. John's wort); drugs known to extend QT interval; 11. Objects with significant changes in diet or exercise habits recently; 12. Subjects who have taken the study drug or participated in the clinical trial of the drug within three months before taking the study drug; 13. 12 lead ECG abnormalities have clinical significance; 14. Female subjects who are in breast-feeding period or whose serum pregnancy results are positive during screening or testing; 15. Patients with clinically significant abnormality in clinical laboratory examination or other clinically significant diseases found within 6 months (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio cerebrovascular diseases); 16. The patients with viral hepatitis (including hepatitis B and C), AIDS antibody and Treponema pallidum antibody were screened positive; 17. From the screening stage to the study of patients with acute disease or medication before medication; 18. Subjects who consumed chocolate, any caffeinated or xanthine rich food or drink 48 hours before taking the study drug; 19. Subjects who had taken any alcoholic product within 48 hours prior to taking the study drug; 20. Drug abuse test positive objects; 21. Objects that do not have the ability or are unable to use the suction device correctly; 22. The researchers believe that there are other factors that are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood drug concentration; | — |
Countries
China
Contacts
Public ContactWeiyong Li
Wuhan Xiangfang clinical pharmacology research center
Outcome results
None listed