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NCT00919867 · ClinicalTrials.gov registry record · Phase 1

A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

A Phase 1 study of Healthy, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
42
Enrollment target
1
Study location

NCT00919867 is a Phase 1 study of Healthy that has completed, run by Shire. The registered enrollment target is 42 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00919867, a Phase 1 study of Healthy, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target
1
Study location

Study Summary

Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

Conditions Studied

Interventions

  • DRUG SPD503
  • DRUG VYVANSE
  • DRUG SPD503 and VYVANSE

Study Locations (1)

New Jersey

  • Advanced Biomedical Research, Inc. - Hackensack

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2009-06-24
Est. Completion 2009-07-30
Phase Phase 1

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00919867

The ClinicalTrials.gov registry entry for NCT00919867 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which SPD503 is the first listed.

NCT00919867 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT00919867 about?

NCT00919867 is a clinical study titled "A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers". Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

What is the current status of trial NCT00919867?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2009-06-24. Estimated completion is 2009-07-30.

What conditions does trial NCT00919867 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00919867?

The interventions under investigation include: SPD503 (DRUG), VYVANSE (DRUG), SPD503 and VYVANSE (DRUG).

Who is sponsoring clinical trial NCT00919867?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00919867 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.