Pharmacokinetic and pharmacodynamic interaction between DWP16001, an sodium–glucose cotransporter 2 inhibitor and metformin in healthy subjects
| العنوان: | Pharmacokinetic and pharmacodynamic interaction between DWP16001, an sodium–glucose cotransporter 2 inhibitor and metformin in healthy subjects |
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| المؤلفون: | Byungwook Kim, Ki Young Huh, Jun Gi Hwang, JaeJin Nah, Wan Huh, Jae Min Cho, In‐Jin Jang, Kyung‐Sang Yu, Yun Kim, SeungHwan Lee |
| المصدر: | British Journal of Clinical Pharmacology. 89:1462-1470 |
| بيانات النشر: | Wiley, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Pharmacology, Pharmacology (medical) |
| الوصف: | DWP16001 is a novel sodium-glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes with selective and sustained sodium-glucose cotransporter 2 inhibition. We aimed to evaluate whether the coadministration of DWP16001 and metformin causes any changes in pharmacokinetics (PK) or pharmacodynamics (PD).A randomized, open-label, single- and multiple-dose, 2-sequence, crossover study was conducted in healthy male subjects. Subjects received the following treatments: a single oral dose of DWP16001 (DWP) 2 mg, metformin immediate release 1000 mg (MET) twice daily for 7 days and a single oral dose of DWP and MET at steady-state for metformin (DWP+MET). Serial blood and interval urine were collected for PK and PD analyses. Safety and tolerability profiles were assessed throughout the study.DWP+MET displayed increased peak concentration and area under the concentration-time curve from time 0 to time of the last quantifiable concentration compared with DWP (per standard bioequivalence boundaries, 0.8-1.25); the geometric mean ratios (GMRs) and their 90% confidence intervals (CIs) were 1.22 (1.13-1.31) and 1.09 (1.05-1.14), respectively. DWP+MET and MET showed similar peak concentration and area under the concentration-time curve within a dosing interval at steady state for metformin; the GMRs and 90% CIs were 0.98 (0.90-1.06) and 1.05 (0.98-1.13), respectively. The amount of urinary glucose excretion from time 0 to 144 h was also comparable between DWP+MET and DWP (GMR and 90% CI; 0.99, 0.94-1.05).The results suggest that DWP16001 and metformin could be coadministered without clinically relevant PK and PD interactions. |
| تدمد: | 1365-2125 0306-5251 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d25b2e7df0d8a895e0de2b6f25e46adc https://doi.org/10.1111/bcp.15613 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi.dedup.....d25b2e7df0d8a895e0de2b6f25e46adc |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 13652125 03065251 |
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