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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2018.1
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- 1 - 11 (11page)
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Background: In type 2 diabetes mellitus therapy, fixed-dose combination (FDC) can offer not only benefits in glucose control via the combined use of agents, but also increase patient compliance. The aim of this study was to assess the pharmacokinetic equivalence of the high dose of the FDC tablet (gemigliptin/metformin sustained release [SR] 50/1,000 mg) and a corresponding co-administered dose of individual tablets. Methods: This study was randomized, open-label, single dose, two treatments, two-period, crossover study, which included 24 healthy subjects. Subjects received the FDC or individual tablets of gemigliptin (50 mg) and metformin XR (1,000 mg) in each period. Geometric mean ratios (GMRs) and 90% confidence intervals (CIs) of maximum plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of the FDC tablet and co-administration of individual tablet for both gemigliptin and metformin were calculated. Results: The GMRs (FDC tablets/co-administration; 90% CIs) for Cmax and AUClast of gemigliptin were 1.079 (0.986–1.180) and 1.047 (1.014–1.080), respectively. For metformin, the GMRs for Cmax, and AUClast were 1.038 (0.995–1.083) and 1.041 (0.997–1.088), respectively. The 90% CIs for GMRs of Cmax and AUClast for gemigliptin and metformin fell entirely within bounds of 0.800–1.250. Both administration of FDC tablet and co-administration of individual tablets were well tolerated. Conclusion: 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.
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참고문헌 (15)
참고문헌 신청
DeFronzo RA / 1988 / Lilly lecture 1987. The triumvirate: beta-cell, muscle, liver. A collusion responsible for NIDDM / Diabetes 37(6):667~687
Turner RC / 1999 / Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group / JAMA 281(21):2005~2012
Russell S / 2013 / Incretin-based therapies for type 2 diabetes mellitus: a review of direct comparisons of efficacy, safety and patient satisfaction / Int J Clin Pharm 35(2):159~172
Deacon CF / 2011 / Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review / Diabetes Obes Metab 13(1):7~18
Kirby M / 2009 / Inhibitor selectivity in the clinical application of dipeptidyl peptidase-4 inhibition / Clin Sci (Lond) 118(1):31~41
Turner RC / 1999 / Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group / JAMA 281(21):2005~2012
Russell S / 2013 / Incretin-based therapies for type 2 diabetes mellitus: a review of direct comparisons of efficacy, safety and patient satisfaction / Int J Clin Pharm 35(2):159~172
Deacon CF / 2011 / Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review / Diabetes Obes Metab 13(1):7~18
Kirby M / 2009 / Inhibitor selectivity in the clinical application of dipeptidyl peptidase-4 inhibition / Clin Sci (Lond) 118(1):31~41
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