IR@PKUHSC  > 北京大学第一临床医学院
学科主题临床医学
Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects
Pichereau, Solen1; Zhao, Xia2; Cui, Yimin2; Zhao, Shuai3; Hohl, Kathrin1; Meinicke, Thomas1; Friedrich, Christian4
关键词Bioavailability Bioequivalence Linagliptin/metformin
刊名INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
2015-07-01
DOI10.5414/CP202237
53期:7页:582-592
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]TYPE-2 DIABETES-MELLITUS ; FIXED-DOSE COMBINATION ; DIPEPTIDYL PEPTIDASE-4 INHIBITOR ; PLACEBO-CONTROLLED TRIAL ; DOUBLE-BLIND ; GLYCEMIC CONTROL ; GLYBURIDE/METFORMIN TABLETS ; METFORMIN ; PHARMACOKINETICS ; EFFICACY
英文摘要

Objective: To evaluate the relative bioavailability of single pill combination (SPC) tablets of linagliptin and metformin compared with separate tablets co-administered in healthy Chinese subjects. Materials and methods: This was an open-label, singledose, randomized, two-period, crossover study in healthy Chinese subjects with two dose groups: linagliptin 2.5 mg/metformin 850 mg and linagliptin 2.5 mg/metformin 500 mg. Within each group (n = 24), subjects received one dose of the SPC tablet in one period and one dose of the separate tablets in the other.. Primary endpoints were area under the plasma concentration time curve from 0 to 72 hours (AUC(0-72)) and maximum plasma concentration (C-max) for linagliptin, and AUC from 0 to the last quantifiable concentration (AUC(0-tz)) and C-max for metformin. Results: With the linagliptin 2.5 mg/metformin 850 mg dose, the adjusted geometric mean ratio of the SPC to the separate tablets for linagliptin was 99.53% (90% confidence interval (CI): 94.75 - 104.55) for AUC(0-72) and 101.93% (90% CI: 95.36 - 108.95) for C-max; for metformin the ratio was 96.99% (90% CI: 90.62 - 103.81) for AUC(0-tz) and 94.64% (90% CI: 85.43 - 104.84) for C-max. With the linagliptin 2.5 mg/metformin 500 mg dose, the ratio with linagliptin for AUC(0-72) and C-max was 100.81% (90% CI: 95.14 - 106.82) and 111.37% (90% CI: 100.40 - 123.54), respectively; the same statistical parameters with metformin for AUC(0-tz) and C-max were 102.95% (90% CI: 96.24 - 110.12) and 102.46% (90% CI: 92.20 - 113.87), respectively. Conclusions: SPC tablets of linagliptin and metformin were bioequivalent to separate tablets co-administered in healthy Chinese subjects.

语种英语
WOS记录号WOS:000358631000012
Citation statistics
Cited Times:2[WOS]   [WOS Record]     [Related Records in WOS]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55900
Collection北京大学第一临床医学院
作者单位1.Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany
2.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
3.Boehringer Ingelheim Shanghai Pharmaceut Co Ltd, Shanghai, Peoples R China
4.Bayer HlthCare Pharmaceut, Berlin, Germany
Recommended Citation
GB/T 7714
Pichereau, Solen,Zhao, Xia,Cui, Yimin,et al. Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects[J]. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,2015,53(7):582-592.
APA Pichereau, Solen.,Zhao, Xia.,Cui, Yimin.,Zhao, Shuai.,Hohl, Kathrin.,...&Friedrich, Christian.(2015).Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects.INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,53(7),582-592.
MLA Pichereau, Solen,et al."Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects".INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 53.7(2015):582-592.
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