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This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has an effect on the pharmacokinetic (PK) profile of midazolam(a cytochrome (CYP) 3A4 substrate)in healthy subjects
This is a single center, open-label study in healthy adult subjects. Total 14 subjects will be enrolled into the study and will be receive study drug per the defined treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam Syrup HEC74647PA HEC110114 | Experimental | Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam Syrup | Drug | Administered Midazolam Syrup 5 mg orally once daily in fed state; |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax) | Day 1, Day9 | |
| Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t) | Day 1, Day9 | |
| Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0- 0-∞) | Day 1, Day9 | |
| Incidence of adverse eventsECG, or Physical Examination. | Day 1 to Day16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Hong, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| HEC74647PA | Drug | Administered HEC74647PA 100 mg orally once daily in fed state; |
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| HEC110114 | Drug | Administered HEC110114 600 mg orally once daily in fed state; |
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