Journal of Bioequivalence & Bioavailability

Tobias Brand

Publications

• Research Article
  Bioequivalence of Glucophage® (Metformin) Tablets from Europe and the United States Tested in Healthy Volunteers
  Author(s): Christian Friedrich, Tobias Brand, Arne Ring and Thomas MeinickeChristian Friedrich, Tobias Brand, Arne Ring and Thomas Meinicke
  
  Objectives: To investigate whether Glucophage® (metformin) tablets from Europe are bioequivalent to Glucophage tablets from the United States (US) despite in vitro dissolution differences. Bioequivalence would indicate that global Phase III data collected with either product is valid for the registration of fixed-dose combinations with metformin in both regions. Research design and methods: This study included two parts, both of which were conducted according to a randomised, open-label, single-dose, two-period crossover design. The subjects of Part I (N=28) received the 1000 mg Glucophage products, and the subjects of Part II (N=28) received the 500 mg Glucophage products. Results: At both dose levels (1000 mg and 500 mg), administration of single doses of Glucophage from Europe and the US resulted in comparable exposures, as determined by AUC0-inf and Cmax of metformin. The geo.. View More»
  DOI: 10.4172/jbb.1000181

  Abstract PDF