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NCT01890785 · ClinicalTrials.gov registry record · Phase 1

Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

A Phase 1 study, sponsored by Shire.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01890785: Completed Phase 1 study, sponsored by Shire.

NCT01890785 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01890785, a Phase 1 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Primary Outcome

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Interventions

  • DRUG Lisdexamfetamine Dimesylate

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2013-07-15
Est. Completion 2013-08-22
Phase Phase 1
Shire

245 total trials

What the finished NCT01890785 record still lists

NCT01890785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Lisdexamfetamine Dimesylate is the first listed.

NCT01890785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01890785 about?

NCT01890785 is a clinical study titled "Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers". Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

What is the current status of trial NCT01890785?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-07-15. Estimated completion is 2013-08-22.

What interventions are being tested in trial NCT01890785?

The interventions under investigation include: Lisdexamfetamine Dimesylate (DRUG).

Who is sponsoring clinical trial NCT01890785?

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

How this trial's enrollment target compares

Where NCT01890785's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01890785, the US trial registry maintained by the National Library of Medicine. NCT01890785 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.