Pharmacokinetics Studies providing pharmacokinetic data Table 4 below shows the studies relating to each PK topic. Table 4: Submitted pharmacokinetic studies. PK topic Subtopic Study ID PK in healthy General PKSingle dose 1245.1 adults 1245.8 1245.5 Multi-dose None Bioequivalence Single dose 1245.51 † 1275.3 1276.5 Multi-dose 1276.9 Food effect 1245.3 1245.79 PK in special Target population § 1245.2 populations Single / multiple dosing 1245.4 Multi-dose PK-PD study Hepatic impairment 1245.13 Renal impairment 1245.12 Neonates/infants/children/ None adolescents Elderly None Other special populations: 1245.44 PK-PD study in Chinese T2DM patients PK-PD study in Japanese T2DM 1245.15 patients Genetic/ Males versus females None gender related PK Other genetic variable None PK Metformin 1245.6 interactions Glimepiride 1245.7 Pioglitazone 1245.17 Warfarin 1245.18
Pharmacokinetics Studies providing pharmacokinetic data Table 4 below shows the studies relating to each PK topic. Table 4: Submitted pharmacokinetic studies. PK topic Subtopic Study ID PK in healthy adults General PKSingle dose Multi-dose 1245.1 1245.8 1245.5 None Bioequivalence † Single dose Multi-dose 1245.51 1275.3 1276.5 1276.9 Food effect 1245.3 1245.79 PK in special populations Target population § Single / multiple dosing Multi-dose PK-PD study 1245.2 1245.4 Hepatic impairment 1245.13 Renal impairment 1245.12 Neonates/infants/children/ adolescents None Elderly None Other special populations: PK-PD study in Chinese T2DM patients PK-PD study in Japanese T2DM patients 1245.44 1245.15 Genetic/ gender related PK Males versus females None Other genetic variable None PK interactions Metformin 1245.6 Glimepiride 1245.7 Pioglitazone 1245.17 Warfarin 1245.18
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