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A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.
The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX000623/Metformin/ JMKX000623+Metformin | Experimental | D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX000623 | Drug | JMKX000623, administered orally ; |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State(AUC0-tau) | baseline through 4 days post-dose | |
| Maximum observed After Reaching steady state concentration (Css,max) | baseline through 4 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence and features of AEs assessed by CTCAE v5.0. | baseline through 4 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaojie Wu, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin |
| Drug |
Metformin,administered orally |
|