Pharmacokinetic Equivalence of the High Dose Strength Fixed-Dose Combination Tablet of Gemigliptin/Metformin Sustained Release (SR) and Individual Component Gemigliptin and Metformin XR Tablets in Healthy Subjects.

Yong-Soon Cho Shi Hyang Lee Hyeong-Seok Lim Kyun-Seop Bae

Published in: Journal of Korean medical science (2018)

FDC tablet exhibited pharmacokinetic equivalence and comparable safety and tolerability to co-administration of corresponding doses of gemigliptin and metformin XR as individual tablets. Trial registry at ClinicalTrials.gov, NCT02056600.

Keyphrases

high dose
low dose
open label
clinical trial
study protocol
phase iii
stem cell transplantation
phase ii
double blind