Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
This is a single-center, randomized, open-label, multi-dose crossover study assessing the
pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy
volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of
diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy
volunteers under fed conditions. Secondary objectives are to assess diazoxide choline
pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and
tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets
in healthy volunteers.