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SPD544 High Strength Bioequivalence Study

NCT01183234 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-06-09

Study results available
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Summary

The purpose of this study is to assess bioequivalence of 2 capsule strengths.

Conditions

  • ADHD

Interventions

DRUG

SPD544

two 30mg capsules, single oral dose

DRUG

Methylphenidate hydrochloride

one 60mg capsule, single oral dose

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
2010-08-27
Primary Completion
2010-10-22
Completion
2010-10-22

Countries

  • United Kingdom

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 NCT01183234 on ClinicalTrials.gov