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NCT01290276 · ClinicalTrials.gov registry record · Phase 1
Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation
A Phase 1 study, sponsored by Tong Lee.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01290276 is a Phase 1 study that has completed, run by Tong Lee. The registered enrollment target is 6 participants.
The verdict
NCT01290276, a Phase 1 study, has completed, sponsored by Tong Lee.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
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.
Interventions
- DRUG Ond-PR1
- DRUG Ond-PR1 + MPh-IR
- DRUG Ond-PR2
- DRUG Ond-PR2 +_ MPh-IR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01290276
The ClinicalTrials.gov registry entry for NCT01290276 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tong Lee, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ond-PR1 is the first listed.
NCT01290276 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01290276 about?
NCT01290276 is a clinical study titled "Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation". 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 Pharm...
What is the current status of trial NCT01290276?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2010-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01290276?
The interventions under investigation include: Ond-PR1 (DRUG), Ond-PR1 + MPh-IR (DRUG), Ond-PR2 (DRUG), Ond-PR2 +_ MPh-IR (DRUG).
Who is sponsoring clinical trial NCT01290276?
This trial is sponsored by Tong Lee, which has 2 total clinical trials registered on ClinicalTrials.gov.
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