Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK)
profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in
normal healthy volunteers. After this initial phase, the investigators will follow with the
Phase Ib study to determine Pharmacokinetic/Pharmacodynamic (PK/PD), safety, and tolerability
interactions following simultaneous administration of these ondansetron formulations with a
10 mg Methylphenidate Immediate Release (MPh-IR) tablet in normal healthy volunteers.