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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
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This is a study of a drug drug interaction between Supaglutide and Digoxin or Metformin.
This is a single-centre, open labeled, fixed-sequence study designed to assess the pharmacokinetic effects of multiple subcutaneous injections of Supalutide on a single oral dose of digoxin or multiple oral doses of metformin. 32 healthy subjects are planned to be enrolled and allocated to 2 parallel trial groups, Digoxin combined with Sulpalutide injection (Group A) and Metformin combined with Sulpalutide injection (Group B), with 16 cases in each group, of which no less than 4 were of a single sex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Digoxin combined with Supaglutide group | Experimental | Subjects will receive a single oral dose of 0.25 mg digoxin tablets on Day 1. And will received subcutaneous injection of sulpalutide QW for five weeks(D5-D33). Then receive another single oral dose of 0.25 mg digoxin tablets on Day 35. |
|
| Group B: Metformin combined with Supaglutide Group | Experimental | Subjects will receive multiple oral dose of Metformin tablets on Day 1-3. And will received subcutaneous injection of sulpalutide QW for five weeks(D5-D33). Then receive another round of Metformin tablets on Day 32-34. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supaglutide injection | Drug | Administered subcutaneously in the Supaglutide arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Group A: Plasma Cmax of digoxin | when given in combination with supaglutide in healthy volunteers | 39 Days |
| Group A: Plasma AUC0-last of digoxin | when given in combination with suplaglutide in healthy volunteers | 39 Days |
| Group A: Plasma AUC0-inf of digoxin | when given in combination with supaglutide in healthy volunteers | 39 Days |
| Group B: Plasma Cmax,ss of Metformin | when given in combination with supaglutide in healthy volunteers | 34 Days |
| Group B: Plasma AUC0-tau of Metformin | when given in combination with suplaglutide in healthy volunteers | 34 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Group A: Plasma Tmax of Digoxin | when given in combination with supaglutide in healthy volunteers | 39 Days |
| Group A: Plasma t1/2 of digoxin | when given in combination with supaglutide in healthy volunteers |
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Inclusion Criteria:
6. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40587051 | Derived | Wu X, He J, Wu J, Liu W, Xu Y, Li Y, Zhang J, Wang Q. Effect of Efsubaglutide Alfa on the Pharmacokinetics of Metformin and Digoxin in Healthy Participants. Clin Pharmacokinet. 2025 Sep;64(9):1367-1377. doi: 10.1007/s40262-025-01541-0. Epub 2025 Jun 30. |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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|
| Digoxin | Drug | Oral Administration |
|
|
| Metformin | Drug | Oral Administration |
|
|
| 39 Days |
| Group A: Plasma CL/F of digoxin | when given in combination with suplaglutide in healthy volunteers | 39 Days |
| Group A: Plasma Vz/F of digoxin | when given in combination with supaglutide in healthy volunteers | 39 Days |
| Group B: Plasma Tmax of Metformin | when given in combination with supaglutide in healthy volunteers | 34 Days |
| Group B: Plasma Cmin,ss of Metformin | when given in combination with suplaglutide in healthy volunteers | 34 Days |
| Group B: Plasma t1/2 of Metformin | when given in combination with suplaglutide in healthy volunteers | 34 Days |
| Group B: Plasma CL/F of Metformin | when given in combination with suplaglutide in healthy volunteers | 34 Days |
| Group B: Plasma Vz/F of metformin | when given in combination with suplaglutide in healthy volunteers | 34 Days |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |