NCT01183234

SPD544 High Strength Bioequivalence Study

Phase 1,Randomized,Open-Label,Two Period Single Dose Crossover Bioequivalence Study of Two Capsule Strengths of SPD544 In Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This will be a randomised, open-label, two-period, single dose, crossover bioequivalence study in healthy subjects under fasting conditions to assess bioequivalence of 1 x 60 mg capsule methylphenidate compared to 2 x 30 mg capsules methylphenidate. Pharmacokinetics and safety will be assessed.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	SPD544	two 30mg capsules, single oral dose
DRUG	Methylphenidate hydrochloride	one 60mg capsule, single oral dose

Timeline

• Start date: 2010-08-27
• Primary completion: 2010-10-22
• Completion: 2010-10-22
• First posted: 2010-08-17
• Last updated: 2021-06-09
• Results posted: 2011-08-25

Locations

1 site across 1 country: United Kingdom