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The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects
This is a 2-part study with each part is an open-label study in healthy adult subjects.
Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1~7 and Day 13~19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Subjects will receive HEC74647 on Day 1~7 and Day13~19, co-administration with HEC110114 on Day13~19. |
|
| Part B | Experimental | Subjects will receive HEC110114 on Day 1~7 and Day13~19, co-administration with HEC74647 on Day13~19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC74647 | Drug | Administered HEC74647 200 mg orally once daily in fed state |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of adverse events | From Days 1-26 |
| Cmax | Maximum plasma concentration of study drugs | Day 7-12 and Day 19-26 |
| AUC | Maximum plasma concentration of study drugs | Day 7-12 and Day 19-26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, Doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| HEC110114 |
| Drug |
Administered HEC110114 800 mg orally once daily in fed state |
|
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |