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This is a open-label, non-randomized, multiple oral dosings, three-period, drug-drug interaction study of JMKX003142 tablet, Amiodarone Hydrochloride Tablets and Febuxostat Tablets in Chinese healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-Drug interaction study of JMKX003142 and Amiodarone | Experimental | 24 Subjects first administered with JMKX003142 tablets 4mg from day 1 to day 7 after breakfast. from day 12 to day 18 the subjects were adminstered with Amiodarone Hydrochloride Tablets 400 mg. from day 22 to day 28 these subjects were co-adminstered with JMKX003142 tablets 4mg and Amiodarone Hydrochloride Tablets 400 mg. |
|
| Drug-Drug interaction study of JMKX003142 with Febuxostat | Experimental | 24 Subjects first administered with JMKX003142 tablets 4mg from day 1 to day 7 after breakfast. from day 12 to day 18 the subjects were adminstered with Febuxostat Tablets 40 mg. from day 21 to day 27 these subjects were co-adminstered with JMKX003142 tablets 4mg and Febuxostat Tablets 40 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone Hydrochloride Tablets | Drug | Cohort 1: The intervention is for study of drug drug interaction of JMKX003142 when administered with Amiodarone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss | up to 7 days | |
| AUC0-tau | up tp 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | up to 7 days | |
| AUC0-t | up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Febuxostat Tablets | Drug | Cohort 2: The intervention is for study of drug drug interaction of JMKX003142 when administered with Febuxostat Tablets |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |