Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
The NO SWITCH list is based on the hypothesis that the pharmacokinetic differences between
different batches of one medicines are smaller than the pharmacokinetic differences between
two medicines (from a different manufacturer, e.g. brand versus generic medicine). The aim of
this study is to investigate the hypothesis using gabapentin as test product. Therefore, the
first objective of this study is to investigate the individual bioequivalence - or
switchability - of Gabasandoz® 800 mg relative to Neurontin 800 mg®. The second objective is
to investigate the individual bioequivalence between two different batches of the same
medicine, for Gabasandoz® 800 mg and Neurontin® 800 mg.