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SPD544 High Strength Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01183234
First received: August 16, 2010
Last updated: August 31, 2011
Last verified: August 2011
Results First Received: July 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: ADHD
Interventions: Drug: SPD544
Drug: Methylphenidate hydrochloride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Equasym XL (SPD544) First, Then Metadate CD Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)
Metadate CD First, Then Equasym XL Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)

Participant Flow for 3 periods

Period 1:   First Intervention
    Equasym XL (SPD544) First, Then Metadate CD     Metadate CD First, Then Equasym XL  
STARTED     14     14  
COMPLETED     13     14  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 2:   Washout
    Equasym XL (SPD544) First, Then Metadate CD     Metadate CD First, Then Equasym XL  
STARTED     13     14  
COMPLETED     13     14  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Equasym XL (SPD544) First, Then Metadate CD     Metadate CD First, Then Equasym XL  
STARTED     13     14  
COMPLETED     13     14  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Equasym XL First, Then Metadate CD Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
Metadate CD First, Then Equasym XL Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)
Total Total of all reporting groups

Baseline Measures
    Equasym XL First, Then Metadate CD     Metadate CD First, Then Equasym XL     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  30.8  ± 10.12     29.5  ± 8.61     30.1  ± 9.24  
Age, Customized  
[units: participants]
     
18 to 55 years     14     14     28  
Gender  
[units: participants]
     
Female     4     7     11  
Male     10     7     17  
Region of Enrollment  
[units: participants]
     
United Kingdom     14     14     28  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Patrick Martin, M.D.
Organization: Shire Pharmaceutical
e-mail: pmartin@shire.com


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01183234     History of Changes
Other Study ID Numbers: SPD544-101
Study First Received: August 16, 2010
Results First Received: July 27, 2011
Last Updated: August 31, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency