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      Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus®) and Lantus® in healthy subjects: a double-blind, randomized clamp study.

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          Abstract

          The objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus® (test) with the innovator's formulation Lantus® (reference) using the euglycemic clamp technique in a single-dose, double-blind, randomized, two sequences, four-period replicate crossover study in healthy volunteers (n = 40).

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          Author and article information

          Journal
          Acta Diabetol
          Acta diabetologica
          Springer Science and Business Media LLC
          1432-5233
          0940-5429
          May 2018
          : 55
          : 5
          Affiliations
          [1 ] Wockhardt, Global Clinical Development, BKC, Mumbai, India.
          [2 ] School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA.
          [3 ] School of Pharmacy, Center for Translational Medicine, University of Maryland, 20 N. Pine Street, Baltimore, MD, 21201, USA. mgopalakrishnan@rx.umaryland.edu.
          [4 ] Wockhardt, Research Center, Aurangabad, India.
          [5 ] Centre for Diabetes and Endocrine Care, Bengaluru, India.
          Article
          10.1007/s00592-018-1113-3
          10.1007/s00592-018-1113-3
          29453671
          688f1cf7-20c2-45aa-a128-29169aef5d2f
          History

          Pharmacokinetics,Bioequivalence,Diabetes mellitus,Insulin glargine,Pharmacodynamics

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