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Pharmacokinetics of Lisdexamfetamine (Vyvanse®) in Post-bariatric Surgery Patients

NCT03070509 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-08-23

No results posted yet for this study

Summary

This study is being conducted to evaluate how the body absorbs and processes the medication lisdexamfetamine (Vyvanse®). Subjects who are 9-15 months post gastric bypass surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete one 12-hour study day and complete one 24-hour post dosing blood draw.

Conditions

  • Lisdexamfetamine

Interventions

DRUG

Lisdexamfetamine

lisdexamfetamine 50 mg single dose

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Neuropsychiatric Research Institute, Fargo, North Dakota

    collaborator OTHER

  • North Dakota State University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2019-07-31
Completion
2019-07-31
FDA Drug
Yes

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 NCT03070509 on ClinicalTrials.gov