NCT01290276

Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation

Phase Ia/Ib Study of Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Tong Lee · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

We will compare 2 different pulsatile-release formulations of ondansetron, PR1 and PR2. Ond-PR1 is a pH-sensitive formulation while Ond-PR2 is osmotic-sensitive.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ond-PR1	Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1)
DRUG	Ond-PR1 + MPh-IR	Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1) plus 10 mg methylphenidate immediate release (Mph-IR)
DRUG	Ond-PR2	Single oral dose of 8 mg ondansetron pulsatile-release formulation 2 (Ond-PR2)
DRUG	Ond-PR2 +_ MPh-IR	Single oral dose of 8 mg of ondansetron pulsatile-release formulation 2 (Ond-PR2) plus 10 mg methylphenidate immediate release (Mph-IR)

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-02-04
• Last updated: 2014-08-01

Locations

1 site across 1 country: United States