메뉴 건너뛰기




Volumn 53, Issue 7, 2015, Pages 582-592

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

Author keywords

Bioavailability; Bioequivalence; Linagliptin metformin

Indexed keywords

LINAGLIPTIN; LINAGLIPTIN PLUS METFORMIN; METFORMIN; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; DRUG COMBINATION; PURINE DERIVATIVE; QUINAZOLINE DERIVATIVE; TABLET;

EID: 84936747423     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP202237     Document Type: Article
Times cited : (3)

References (31)
  • 1
    • 84870816352 scopus 로고    scopus 로고
    • Available at Last accessed July 24, 2014
    • International Diabetes Federation. Diabetes Atlas, sixth edition. Available at: http://www.idf.org/sites/default/files/EN-6E-Atlas-Full-0.pdf. Last accessed July 24, 2014.
    • Diabetes Atlas, Sixth Edition
  • 2
    • 84919999219 scopus 로고    scopus 로고
    • Management of hyperglycemia in type 2 diabetes: A patient-centered approach: Update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)
    • CrossRef PubMed
    • Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: Update to a position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2015; 38: 140-149. CrossRef PubMed
    • (2015) Diabetes Care , vol.38 , pp. 140-149
    • Inzucchi, S.E.1    Bergenstal, R.M.2    Buse, J.B.3    Diamant, M.4    Ferrannini, E.5    Nauck, M.6    Peters, A.L.7    Tsapas, A.8    Wender, R.9    Matthews, D.R.10
  • 4
    • 77952118055 scopus 로고    scopus 로고
    • Boehringer Ingelheim. Available at Last accessed July 24, 2014
    • Trajenta. Summary of Product Characteristics. Boehringer Ingelheim. Available at: http://www.medicines.org.uk/emc/medicine/25000/SPC/Trajenta+5+mg+film-coated+tablets/. Last accessed July 24, 2014.
    • Summary of Product Characteristics
  • 5
    • 78851472527 scopus 로고    scopus 로고
    • Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: A randomized controlled trial
    • CrossRef PubMed
    • Del Prato S, Barnett AH, Huisman H, Neubacher D, Woerle HJ, Dugi KA. Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab. 2011; 13: 258-267. CrossRef PubMed
    • (2011) Diabetes Obes Metab , vol.13 , pp. 258-267
    • Del Prato, S.1    Barnett, A.H.2    Huisman, H.3    Neubacher, D.4    Woerle, H.J.5    Dugi, K.A.6
  • 6
    • 79953174825 scopus 로고    scopus 로고
    • Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type 2 diabetes: A randomized, double-blind, placebo-controlled study
    • CrossRef PubMed
    • Gomis R, Espadero RM, Jones R, Woerle HJ, Dugi KA. Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2011; 13: 653-661. CrossRef PubMed
    • (2011) Diabetes Obes Metab , vol.13 , pp. 653-661
    • Gomis, R.1    Espadero, R.M.2    Jones, R.3    Woerle, H.J.4    Dugi, K.A.5
  • 7
    • 78649691630 scopus 로고    scopus 로고
    • Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled study
    • CrossRef PubMed
    • Taskinen MR, Rosenstock J, Tamminen I, Kubiak R, Patel S, Dugi KA, Woerle HJ. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2011; 13: 65-74. CrossRef PubMed
    • (2011) Diabetes Obes Metab , vol.13 , pp. 65-74
    • Taskinen, M.R.1    Rosenstock, J.2    Tamminen, I.3    Kubiak, R.4    Patel, S.5    Dugi, K.A.6    Woerle, H.J.7
  • 8
    • 84861683713 scopus 로고    scopus 로고
    • Clinical pharmacokinetics and pharmacodynamics of linagliptin
    • CrossRef PubMed
    • Graefe-Mody U, Retlich S, Friedrich C. Clinical pharmacokinetics and pharmacodynamics of linagliptin. Clin Pharmacokinet. 2012; 51: 411-427. CrossRef PubMed
    • (2012) Clin Pharmacokinet , vol.51 , pp. 411-427
    • Graefe-Mody, U.1    Retlich, S.2    Friedrich, C.3
  • 9
    • 72049121944 scopus 로고    scopus 로고
    • Linagliptin, a xanthine-based dipeptidyl peptidase-4 inhibitor with an unusual profile for the treatment of type 2 diabetes
    • CrossRef PubMed
    • Deacon CF, Holst JJ. Linagliptin, a xanthine-based dipeptidyl peptidase-4 inhibitor with an unusual profile for the treatment of type 2 diabetes. Expert Opin Investig Drugs. 2010; 19: 133-140. CrossRef PubMed
    • (2010) Expert Opin Investig Drugs , vol.19 , pp. 133-140
    • Deacon, C.F.1    Holst, J.J.2
  • 10
    • 79953189076 scopus 로고    scopus 로고
    • Linagliptin: In type 2 diabetes mellitus
    • CrossRef PubMed
    • Scott LJ. Linagliptin: in type 2 diabetes mellitus. Drugs. 2011; 71: 611-624. CrossRef PubMed
    • (2011) Drugs , vol.71 , pp. 611-624
    • Scott, L.J.1
  • 11
    • 79956078204 scopus 로고    scopus 로고
    • A systematic review of adherence, treatment satisfaction and costs, in fixed-dose combination regimens in type 2 diabetes
    • CrossRef PubMed
    • Hutchins V, Zhang B, Fleurence RL, Krishnarajah G, Graham J. A systematic review of adherence, treatment satisfaction and costs, in fixed-dose combination regimens in type 2 diabetes. Curr Med Res Opin. 2011; 27: 1157-1168. CrossRef PubMed
    • (2011) Curr Med Res Opin , vol.27 , pp. 1157-1168
    • Hutchins, V.1    Zhang, B.2    Fleurence, R.L.3    Krishnarajah, G.4    Graham, J.5
  • 12
    • 84899947620 scopus 로고    scopus 로고
    • Bioequivalence of linagliptin 5 mg once daily and 2.5 mg twice daily: Pharmacokinetics and pharmacodynamics in an open-label crossover trial
    • PubMed
    • Friedrich C, Jungnik A, Retlich S, Ring A, Meinicke T. Bioequivalence of linagliptin 5 mg once daily and 2.5 mg twice daily: pharmacokinetics and pharmacodynamics in an open-label crossover trial. Drug Res (Stuttg). 2014; 64: 269-275. 10.1055/s-0033-1357144 PubMed
    • (2014) Drug Res (Stuttg) , vol.64 , pp. 269-275
    • Friedrich, C.1    Jungnik, A.2    Retlich, S.3    Ring, A.4    Meinicke, T.5
  • 13
    • 84866651423 scopus 로고    scopus 로고
    • Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: A randomised, double-blind, placebo-controlled trial
    • CrossRef PubMed
    • Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012; 28: 1465-1474. CrossRef PubMed
    • (2012) Curr Med Res Opin , vol.28 , pp. 1465-1474
    • Ross, S.A.1    Rafeiro, E.2    Meinicke, T.3    Toorawa, R.4    Weber-Born, S.5    Woerle, H.J.6
  • 14
    • 84899452185 scopus 로고    scopus 로고
    • Linagliptin fixed-dose combination with metformin is bioequivalent to co-administration of linagliptin and metformin as individual tablets
    • PubMed
    • Buschke S, Ring A, Friedrich C, Metzmann K, Meinicke T. Linagliptin fixed-dose combination with metformin is bioequivalent to co-administration of linagliptin and metformin as individual tablets. Int J Clin Pharmacol Ther. 2014; 52: 537-548. 10.5414/CP201960 PubMed
    • (2014) Int J Clin Pharmacol Ther , vol.52 , pp. 537-548
    • Buschke, S.1    Ring, A.2    Friedrich, C.3    Metzmann, K.4    Meinicke, T.5
  • 16
    • 67649932264 scopus 로고    scopus 로고
    • Available at Last accessed July 24, 2014
    • European Medicines Agency. Committee for Medicinal Products for Human use (CHMP). Guideline on the investigation of bioequivalence. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/01/WC500070039.pdf. Last accessed July 24, 2014
    • Guideline on the Investigation of Bioequivalence
  • 17
    • 51849103389 scopus 로고    scopus 로고
    • Safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of BI 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers
    • CrossRef PubMed
    • Hüttner S, Graefe-Mody EU, Withopf B, Ring A, Dugi KA. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of BI 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers. J Clin Pharmacol. 2008; 48: 1171-1178. CrossRef PubMed
    • (2008) J Clin Pharmacol , vol.48 , pp. 1171-1178
    • Hüttner, S.1    Graefe-Mody, E.U.2    Withopf, B.3    Ring, A.4    Dugi, K.A.5
  • 18
    • 0005905707 scopus 로고    scopus 로고
    • Rockville, MD: U.S. Food and Drug Administration, Rockville, MD Available from Last accessed January 14, 2015
    • Guidance for Industry. Bioanalytical method validation. Rockville, MD: U.S. Food and Drug Administration, Rockville, MD; 2001. Available from: http://www.fda.gov/downloads/Drugs/Guida?nces/ucm070107.pdf.: Last accessed January 14, 2015.
    • (2001) Bioanalytical Method Validation
    • Guidance for Industry1
  • 19
    • 77954798308 scopus 로고    scopus 로고
    • Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type 2 diabetes mellitus: A Phase I, randomized, double-blind, placebo-controlled trial of single and multiple escalating doses in healthy adult male Japanese subjects
    • CrossRef PubMed
    • Sarashina A, Sesoko S, Nakashima M, Hayashi N, Taniguchi A, Horie Y, Graefe-Mody EU, Woerle HJ, Dugi KA. Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type 2 diabetes mellitus: a Phase I, randomized, double-blind, placebo-controlled trial of single and multiple escalating doses in healthy adult male Japanese subjects. Clin Ther. 2010; 32: 1188-1204. CrossRef PubMed
    • (2010) Clin Ther , vol.32 , pp. 1188-1204
    • Sarashina, A.1    Sesoko, S.2    Nakashima, M.3    Hayashi, N.4    Taniguchi, A.5    Horie, Y.6    Graefe-Mody, E.U.7    Woerle, H.J.8    Dugi, K.A.9
  • 20
    • 84870212091 scopus 로고    scopus 로고
    • Pharmacokinetics of single and multiple oral doses of 5 mg linagliptin in healthy Chinese volunteers
    • CrossRef PubMed
    • Friedrich C, Shi X, Zeng P, Ring A, Woerle HJ, Patel S. Pharmacokinetics of single and multiple oral doses of 5 mg linagliptin in healthy Chinese volunteers. Int J Clin Pharmacol Ther. 2012; 50: 889-895. CrossRef PubMed
    • (2012) Int J Clin Pharmacol Ther , vol.50 , pp. 889-895
    • Friedrich, C.1    Shi, X.2    Zeng, P.3    Ring, A.4    Woerle, H.J.5    Patel, S.6
  • 23
    • 67649998759 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients
    • CrossRef PubMed
    • Heise T, Graefe-Mody EU, Hüttner S, Ring A, Trommeshauser D, Dugi KA. Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients. Diabetes Obes Metab. 2009; 11: 786-794. CrossRef PubMed
    • (2009) Diabetes Obes Metab , vol.11 , pp. 786-794
    • Heise, T.1    Graefe-Mody, E.U.2    Hüttner, S.3    Ring, A.4    Trommeshauser, D.5    Dugi, K.A.6
  • 24
    • 0032983666 scopus 로고    scopus 로고
    • Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: Progressive requirement for multiple therapies (UKPDS 49)
    • CrossRef PubMed
    • Turner RC, Cull CA, Frighi V, Holman RR; UK Prospective Diabetes Study (UKPDS) Group. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281: 2005-2012. CrossRef PubMed
    • (1999) JAMA , vol.281 , pp. 2005-2012
    • Turner, R.C.1    Cull, C.A.2    Frighi, V.3    Holman, R.R.4
  • 25
    • 0043132411 scopus 로고    scopus 로고
    • Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes
    • CrossRef PubMed
    • Garber AJ, Donovan DS Jr, Dandona P, Bruce S, Park JS. Efficacy of glyburide/metformin tablets compared with initial monotherapy in type 2 diabetes. J Clin Endocrinol Metab. 2003; 88: 3598-3604. CrossRef PubMed
    • (2003) J Clin Endocrinol Metab , vol.88 , pp. 3598-3604
    • Garber, A.J.1    Donovan, D.S.2    Dandona, P.3    Bruce, S.4    Park, J.S.5
  • 26
    • 47849114497 scopus 로고    scopus 로고
    • Fixed combinations in the management of hypertension: Patient perspectives and rationale for development and utility of the olmesartan-amlodipine combination
    • PubMed
    • Pimenta E, Oparil S. Fixed combinations in the management of hypertension: patient perspectives and rationale for development and utility of the olmesartan-amlodipine combination. Vasc Health Risk Manag. 2008; 4: 653-664. PubMed
    • (2008) Vasc Health Risk Manag , vol.4 , pp. 653-664
    • Pimenta, E.1    Oparil, S.2
  • 27
    • 0344897714 scopus 로고    scopus 로고
    • Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin
    • CrossRef PubMed
    • Blonde L, Wogen J, Kreilick C, Seymour AA. Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin. Diabetes Obes Metab. 2003; 5: 424-431. CrossRef PubMed
    • (2003) Diabetes Obes Metab , vol.5 , pp. 424-431
    • Blonde, L.1    Wogen, J.2    Kreilick, C.3    Seymour, A.A.4
  • 28
    • 84857902902 scopus 로고    scopus 로고
    • Fixed-dose combination antidiabetic therapy: Real-world factors associated with prescribing choices and relationship with patient satisfaction and compliance
    • CrossRef PubMed
    • Benford M, Milligan G, Pike J, Anderson P, Piercy J, Fermer S. Fixed-dose combination antidiabetic therapy: real-world factors associated with prescribing choices and relationship with patient satisfaction and compliance. Adv Ther. 2012; 29: 26-40. CrossRef PubMed
    • (2012) Adv Ther , vol.29 , pp. 26-40
    • Benford, M.1    Milligan, G.2    Pike, J.3    Anderson, P.4    Piercy, J.5    Fermer, S.6
  • 29
    • 34250179723 scopus 로고    scopus 로고
    • Fixed-dose combinations improve medication compliance: A meta-analysis
    • CrossRef PubMed
    • Bangalore S, Kamalakkannan G, Parkar S, Messerli FH. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007; 120: 713-719. CrossRef PubMed
    • (2007) Am J Med , vol.120 , pp. 713-719
    • Bangalore, S.1    Kamalakkannan, G.2    Parkar, S.3    Messerli, F.H.4
  • 30
    • 0031472452 scopus 로고    scopus 로고
    • Efficacy of metformin in type II diabetes: Results of a double-blind, placebo-controlled, dose-response trial
    • CrossRef PubMed
    • Garber AJ, Duncan TG, Goodman AM, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997; 103: 491-497. CrossRef PubMed
    • (1997) Am J Med , vol.103 , pp. 491-497
    • Garber, A.J.1    Duncan, T.G.2    Goodman, A.M.3    Mills, D.J.4    Rohlf, J.L.5
  • 31
    • 84903990834 scopus 로고    scopus 로고
    • Effect of food and tablet-dissolution characteristics on the bioavailability of linagliptin fixed-dose combination with metformin: Evidence from two randomized trials
    • PubMed
    • Metzmann K, Schnell D, Jungnik A, Ring A, Theodor R, Hohl K, Meinicke T, Friedrich C. Effect of food and tablet-dissolution characteristics on the bioavailability of linagliptin fixed-dose combination with metformin: evidence from two randomized trials. Int J Clin Pharmacol Ther. 2014; 52: 549-563. 10.5414/CP201961 PubMed
    • (2014) Int J Clin Pharmacol Ther , vol.52 , pp. 549-563
    • Metzmann, K.1    Schnell, D.2    Jungnik, A.3    Ring, A.4    Theodor, R.5    Hohl, K.6    Meinicke, T.7    Friedrich, C.8


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.