A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Hetrombopag Olamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2 Signed informed consent. Exclusion Criteria: 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 Having deep vein thrombosis or other thrombotic diseases. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur. Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec) Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive. Those who have a history of allergies to drugs , food or test drugs or similar drugs; Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study Those who took any drug within 14 days before the test (including Chinese herbal medicine) Any drug that inhibits or induces liver drug metabolism within 30 days before the test Subjects have participated in other clinical trial within the 3 months prior to study entry. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hetrombopag Olamine A<br>health subjects received 7.5 mg Hetrombopag Olamine while fasting. | Drug: Hetrombopag Olamine<br>* 7.5mg in each cycle<br>|
| Active Comparator: Hetrombopag Olamine B<br>health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine | Drug: Hetrombopag Olamine<br>* 7.5mg in each cycle<br>|
| Active Comparator: Hetrombopag Olamine C<br>health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine | Drug: Hetrombopag Olamine<br>* 7.5mg in each cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | from baseline up to Day 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |