title: Evaluation of drug-drug interaction between henagliflozin, a novel sodium-glucose co-transporter 2 inhibitor, and metformin in healthy Chinese males.
abstract: 1. Henagliflozin is a novel sodium-glucose transporter 2 inhibitor and presents a complementary therapy to metformin for patients with T2DM due to its insulin-independent mechanism of action. This study evaluated the potential pharmacokinetic drug-drug interaction between henagliflozin and metformin in healthy Chinese male subjects. 2. In open-label, single-center, single-arm, two-period, three-treatment self-control study, 12 subjects received 25 mg henagliflozin, 1000 mg metformin or the combination. Lack of PK interaction was defined as the ratio of geometric means and 90% confidence interval (CI) for combination: monotherapy being within the range of 0.80-1.25. 3. Co-administration of henagliflozin with metformin had no effect on henagliflozin area under the plasma concentration-time curve (AUC0-24) (GRM: 1.08; CI: 1.05, 1.10) and peak plasma concentration (Cmax) (GRM: 0.99; CI: 0.92, 1.07). Reciprocally, co-administration of metformin with henagliflozin had no clinically significant on metformin AUC0-24 (GRM: 1.09, CI: 1.02, 1.16) although there was an 11% increase in metformin Cmax (GRM 1.12; CI 1.02, 1.23). All monotherapies and combination therapy were well tolerated. 4. Henagliflozin can be co-administered with metformin without dose adjustment of either drug.
authors.affiliation: a Center of Drug Metabolism and Pharmacokinetics , China Pharmaceutical University , Nanjing , P.R. China .
authors.forename: Liupeng
authors.initials: L
authors.lastname: Wang
authors.affiliation: b Department of Pharmaceutical Analysis , China Pharmaceutical University , Nanjing , P.R. China .
authors.forename: Chunyong
authors.initials: C
authors.lastname: Wu
authors.affiliation: a Center of Drug Metabolism and Pharmacokinetics , China Pharmaceutical University , Nanjing , P.R. China .
authors.forename: Lu
authors.initials: L
authors.lastname: Shen
authors.affiliation: c Jiang Su Heng Rui Medcine Co, Ltd , Lianyungang , P.R. China .
authors.forename: Haiyan
authors.initials: H
authors.lastname: Liu
authors.affiliation: c Jiang Su Heng Rui Medcine Co, Ltd , Lianyungang , P.R. China .
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.affiliation: d Jiangsu Province Hospital of Traditional Chinese Medicine , Nanjing , P.R. China , and.
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.affiliation: e Department of Pharmacology , China Pharmaceutical University , Nanjing , P.R. China.
authors.forename: Youqun
authors.initials: Y
authors.lastname: Wang
authors.affiliation: a Center of Drug Metabolism and Pharmacokinetics , China Pharmaceutical University , Nanjing , P.R. China .
authors.forename: Jin
authors.initials: J
authors.lastname: Yang
mesh_terms: D000328:Adult; D044466:Asian People; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000494:pharmacology*; D002681:China; D004347:Drug Interactions; D006801:Humans; D008297:Male; D008687:Metformin / Q000494:pharmacology*; D051297:Sodium-Glucose Transporter 2 / Q000378:metabolism; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D055815:Young Adult
chemical_list: D019086:Bridged Bicyclo Compounds, Heterocyclic; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C000611095:henagliflozin; D008687:Metformin
keywords: Drug-drug interaction; SGLT2 inhibitor; henagliflozin; metformin; type 2 diabetes mellitus