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Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects.
Int J Clin Pharmacol Ther. 2015 Jul; 53(7):582-92.IJ

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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26073354

Citation

Pichereau, Solen, et al. "Relative Bioavailability Study of Linagliptin/metformin Tablets in Healthy Chinese Subjects." International Journal of Clinical Pharmacology and Therapeutics, vol. 53, no. 7, 2015, pp. 582-92.
Pichereau S, Zhao X, Cui Y, et al. Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects. Int J Clin Pharmacol Ther. 2015;53(7):582-92.
Pichereau, S., Zhao, X., Cui, Y., Zhao, S., Hohl, K., Meinicke, T., & Friedrich, C. (2015). Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects. International Journal of Clinical Pharmacology and Therapeutics, 53(7), 582-92. https://doi.org/10.5414/CP202237
Pichereau S, et al. Relative Bioavailability Study of Linagliptin/metformin Tablets in Healthy Chinese Subjects. Int J Clin Pharmacol Ther. 2015;53(7):582-92. PubMed PMID: 26073354.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relative bioavailability study of linagliptin/metformin tablets in healthy Chinese subjects. AU - Pichereau,Solen, AU - Zhao,Xia, AU - Cui,Yimin, AU - Zhao,Shuai, AU - Hohl,Kathrin, AU - Meinicke,Thomas, AU - Friedrich,Christian, PY - 2015/06/23/accepted PY - 2015/6/16/entrez PY - 2015/6/16/pubmed PY - 2015/10/2/medline SP - 582 EP - 92 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 53 IS - 7 N2 - 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. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/26073354/Relative_bioavailability_study_of_linagliptin/metformin_tablets_in_healthy_Chinese_subjects_ L2 - http://www.dustri.com/nc/journals-in-english?artId=13463 DB - PRIME DP - Unbound Medicine ER -