Immune Thrombocytopenia
Conditions
Brief summary
This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.
Interventions
7.5mg in each cycle
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥ 18 years old 2. The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2 3. Signed informed consent.
Exclusion criteria
1. Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results 2. Having deep vein thrombosis or other thrombotic diseases. 3. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur. 4. Extended QT interval during the screening period (calculated in Bazett's method, males \>450 msec) 5. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive. 6. Those who have a history of allergies to drugs , food or test drugs or similar drugs; 7. Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study 8. Those who took any drug within 14 days before the test (including Chinese herbal medicine) 9. Any drug that inhibits or induces liver drug metabolism within 30 days before the test 10. Subjects have participated in other clinical trial within the 3 months prior to study entry. 11. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | from baseline up to Day 26 |
Secondary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) | pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group |
| Area under the plasma concentration versus time curve (AUC) | pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group |
Countries
China
Outcome results
None listed