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NCT01235338 · ClinicalTrials.gov registry record · Phase 1
Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01235338 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 80 participants.
The verdict
NCT01235338, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.
Interventions
- DRUG LDX + Venlafaxine XR
- DRUG Venlafaxine XR + LDX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-10-28 |
| Est. Completion | 2011-01-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01235338
The ClinicalTrials.gov registry entry for NCT01235338 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LDX + Venlafaxine XR is the first listed.
NCT01235338 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01235338 about?
NCT01235338 is a clinical study titled "Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers". This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected ...
What is the current status of trial NCT01235338?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2010-10-28. Estimated completion is 2011-01-17.
What interventions are being tested in trial NCT01235338?
The interventions under investigation include: LDX + Venlafaxine XR (DRUG), Venlafaxine XR + LDX (DRUG).
Who is sponsoring clinical trial NCT01235338?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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