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A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrochlorothiazide、Henagliflozin Proline | Drug | Hydrochlorothiazide and Henagliflozin Proline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss | Day 10, Day 14 | |
| Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max | Day 10, Day 14 | |
| Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss | Day 4, Day 14 | |
| Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max | Day 4, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of Henagliflozin Proline: Tmax | Day 10, Day 14 | |
| Pharmacokinetics parameters of Henagliflozin Proline: t1/2 | Day 10, Day 14 | |
| Pharmacokinetics parameters of Henagliflozin Proline: CL/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38828023 | Derived | Chen Q, Yu C, Wu Q, Song R, Liu Y, Feng S, Yu C, Jia J. Evaluation of Drug-Drug Interaction Between Henagliflozin and Hydrochlorothiazide in Healthy Chinese Volunteers. Drug Des Devel Ther. 2024 May 29;18:1855-1864. doi: 10.2147/DDDT.S433377. eCollection 2024. |
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Evaluation of drug-drug interaction between Henagliflozin Proline and Hydrochlorothiazide. A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.
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| Day 10, Day 14 |
| Pharmacokinetics parameters of Hydrochlorothiazide: Tmax | Day 4, Day 14 |
| Pharmacokinetics parameters of Hydrochlorothiazide: t1/2 | Day 4, Day 14 |
| Pharmacokinetics parameters of Hydrochlorothiazide: CL/F | Day 4, Day 14 |
| Accumulated urine electrolyte excretion 24 hours after administration | Day 4, Day 14 |
| Urinary volume at 24 hours after administration | Day 4, Day 10, Day 14 |
| Accumulated urine glucose excretion within 24 hours after administration | Day 10, Day 14 |
| Adverse events | Day 4, Day 14 |