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NCT00901576 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
38
Enrollment target

NCT00901576 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 38 participants.

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The verdict

NCT00901576, a Phase 1 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
38 participants
Enrollment target

Study Summary

This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.

Interventions

  • DRUG SPD503
  • DRUG Concerta
  • DRUG SPD503 + Concerta

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2009-05-18
Est. Completion 2009-07-06
Phase Phase 1

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00901576

The ClinicalTrials.gov registry entry for NCT00901576 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 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 3 interventions - of which SPD503 is the first listed.

NCT00901576 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00901576 about?

NCT00901576 is a clinical study titled "A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers". This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.

What is the current status of trial NCT00901576?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2009-05-18. Estimated completion is 2009-07-06.

What interventions are being tested in trial NCT00901576?

The interventions under investigation include: SPD503 (DRUG), Concerta (DRUG), SPD503 + Concerta (DRUG).

Who is sponsoring clinical trial NCT00901576?

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

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.