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

Jiangsu HengRui Medicine Co., Ltd.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia

Interventions

Hetrombopag OlamineDRUG

7.5mg in each cycle

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The third xiangya hospital Hospital,of central south university

Changsha, Hunan, China

Outcomes

Primary Outcomes

Adverse events

Time frame: from baseline up to Day 26

Secondary Outcomes

Peak Plasma Concentration (Cmax)

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

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