Arzneimittel Forsch
-
Arzneimittel Forsch · Feb 2012
Randomized Controlled TrialPharmacokinetics, pharmacodynamics, and tolerability of a generic formulation of exenatide: a randomized, open-label, single- and multiple-dose study in healthy Chinese volunteers.
A randomized, open-label, dose-escalating study was designed to assess the pharmacokinetics, pharmacodynamics and tolerability of single and multiple subcutaneous administrations of exenatide in 24 healthy Chinese volunteers. The effects of gender on the pharmacokinetics of exenatide were also evaluated. Subjects were randomized to receive a single and multiple subcutaneous doses of 5 or 10 μg of exenatide. ⋯ No significant gender differences were noted for pharmacokinetic variables. Both exenatide doses were associated with significant reductions in serum glucose levels. Adverse events were mainly of gastrointestinal origin and their incidence was dose-dependent.