SPD544 High Strength Bioequivalence Study
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|ClinicalTrials.gov Identifier: NCT01183234|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : August 25, 2011
Last Update Posted : September 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Drug: SPD544 Drug: Methylphenidate hydrochloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1,Randomized,Open-Label,Two Period Single Dose Crossover Bioequivalence Study of Two Capsule Strengths of SPD544 In Healthy Volunteers.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
|Experimental: SPD544 (Equasym XL)||
two 30mg capsules, single oral dose
Other Name: Equasym XL
|Experimental: Methylphenidate hydrochloride (Metadate CD )||
Drug: Methylphenidate hydrochloride
one 60mg capsule, single oral dose
Other Name: Metadate CD
- 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) [ Time Frame: 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.
- Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD) [ Time Frame: 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.
- Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183234
|London, United Kingdom|
|Principal Investigator:||Dr. Muna Albayaty||Paraxel International|