Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or
gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn
alone and in combination as well as the tolerability of morphine administered with GEn. The
dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be
administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a
controlled release formulation of morphine will be given. Blood samples for evaluation of
gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect
of co-administering both treatments will be assessed using visual analog scales for
somnolence/sedation, dizziness and nausea.