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- Title
Pharmacokinetics of Henagliflozin in Dialysis Patients with Diabetes.
- Authors
Ding, Li; Liu, Shang; Yan, Hao; Li, Zhenyuan; Zhou, Yijun; Pang, Huihua; Lu, Renhua; Zhang, Weiming; Che, Miaolin; Wang, Lin; Wang, Qin; Fang, Wei; Zhang, Minfang; Che, Xiajing; Gu, Leyi
- Abstract
Aim: This study aimed to assess the pharmacokinetics of henagliflozin in dialysis patients with diabetes. Methods: In this prospective, randomized, open-label study where 10 hemodialysis and 10 peritoneal dialysis patients with diabetes were randomized in a 1:1:1:1 ratio to oral administration of henagliflozin in doses of 5 and 10 mg/day. The pharmacokinetics of a single dose of henagliflozin on Days 1 and 2, the minimum plasma concentration (Cmin) of the steady state on Day 10, and single hemodialysis clearance of henagliflozin were measured. Results: The mean values of Cmax were 70.2–77.0 ng/mL and 105–143 ng/mL in the 5 mg and 10 mg henagliflozin groups, respectively; the mean values of AUCinf were 777–811 h*ng/mL and 1290–1730 h*ng/mL in the 5 mg and 10 mg henagliflozin groups, respectively. The median Tmax values ranged from 1 to 3 h across the dose range. The mean values of T1/2 of henagliflozin were 14.1–14.5 and 16.2–21.0 h in the 5 mg and 10 mg groups, respectively. The Cmin values of the steady state in dialysis patients taking 5 mg and 10 mg of henagliflozin were 15.0 ± 4.4 ng/mL and 26.8 ± 16.3 ng/mL, respectively, which were 123.8% and 131.0% higher than those in diabetic patients with normal renal function, respectively. Henagliflozin concentration was decreased by 1.1% after hemodialysis treatment. No treatment-related serious adverse events or discontinuations occurred. Conclusions: Henagliflozin at the current recommended dosage may be safe, although it is possible to result in slight accumulation in patients on dialysis. Registration: Chinese Clinical Trial Registry number ChiCTR2200062872. The date of registration: August 22, 2022.
- Subjects
HEMODIALYSIS patients; PEOPLE with diabetes; ORAL drug administration; PHARMACOKINETICS; ADVERSE health care events
- Publication
Clinical Pharmacokinetics, 2023, Vol 62, Issue 11, p1581
- ISSN
0312-5963
- Publication type
Article
- DOI
10.1007/s40262-023-01300-z