SPD544 High Strength Bioequivalence Study

Phase 1

Completed

• Conditions: ADHD
• Interventions: Drug: SPD544; Drug: Methylphenidate hydrochloride

• Registration Number: NCT01183234
• Lead Sponsor: Shire

Brief 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.

Study Timeline

• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Study Start: 2010-08-27
• Primary Completion: 2010-10-22
• Study Completion: 2010-10-22
• Results First Submitted: 2011-07-27
• Results First Submitted QC: 2011-07-27
• Results First Posted: 2011-08-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPD544 (Equasym XL)	SPD544	-
Methylphenidate hydrochloride (Metadate CD )	Methylphenidate hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)	predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose	Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)	predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose	AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. 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.
Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)	predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose	Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.

Trial Locations

Locations (1)

Paraxel International; 🇬🇧 London, United Kingdom