NDLI: Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Pichereau, Solen Zhao, Xia Cui, Yimin Zhao, Shuai Hohl, Kathrin Meinicke, Thomas Friedrich, Christian
Spatial Coverage	China
Abstract	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, single-dose, 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 (AUC0-72) and maximum plasma concentration (Cmax) for linagliptin, and AUC from 0 to the last quantifiable concentration (AUC0-tz) and Cmax 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 AUC0-72 and 101.93% (90% CI: 95.36-108.95) for Cmax; for metformin the ratio was 96.99% (90% CI: 90.62-103.81) for AUC0-tz and 94.64% (90% CI: 85.43-104.84) for Cmax. With the linagliptin 2.5 mg/metformin 500 mg dose, the ratio with linagliptin for AUC0-72 and Cmax 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 AUC0-tz and Cmax 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.
File Format	HTM / HTML
ISSN	09461965
Issue Number	7
Volume Number	53
Journal	Int. Journal of Clinical Pharmacology and Therapeutics
Language	English
Publisher	Dustri-Verlag
Publisher Date	2015-07-01
Publisher Place	Germany
Access Restriction	Subscribed
Subject Keyword	Discipline Pharmacology Dipeptidyl-peptidase Iv Inhibitors Pharmacokinetics Hypoglycemic Agents Metformin Purines Quinazolines Administration, Oral Adult Area Under Curve Asian Continental Ancestry Group Biological Availability China Cross-over Studies Administration & Dosage Adverse Effects Blood Drug Combinations Female Half-life Healthy Volunteers Humans Linagliptin Male Metabolic Clearance Rate Tablets Young Adult Comparative Study Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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