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

NCT01890785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-03

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Lisdexamfetamine Dimesylate

Single dose of a 70 mg capsule on Day 1

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-15
Primary Completion
2013-08-22
Completion
2013-08-22

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01890785 on ClinicalTrials.gov