drugset / Trial / NCT01290276
Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylphenidate | Small molecule | 10 mg | Oral |
| Subject | Ondansetron | Other / unclassified | 8 mg | Oral |
Indications
No indication recorded.