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

NCT01290276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-08-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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)

Sponsors & Collaborators

  • Tong Lee

    lead OTHER

Principal Investigators

  • Robert Noveck, MD, PhD · Duke University

  • Ashwin Patkar, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290276 on ClinicalTrials.gov