Avandamet Bioequivalence Study Brazil - Fed Administration

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332071
First received: August 31, 2010
Last updated: April 14, 2011
Last verified: April 2011
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Conditions: Healthy Volunteers
Diabetes Mellitus, Type 2
Interventions: Drug: Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg
Drug: Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Test Product in Period 1; Reference Product in Period 2 Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
Reference Product in Period 1; Test Product in Period 2 Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2

Participant Flow for 3 periods

Period 1:   Period 1
    Test Product in Period 1; Reference Product in Period 2     Reference Product in Period 1; Test Product in Period 2  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  

Period 2:   7-Day Washout Period
    Test Product in Period 1; Reference Product in Period 2     Reference Product in Period 1; Test Product in Period 2  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  

Period 3:   Period 2
    Test Product in Period 1; Reference Product in Period 2     Reference Product in Period 1; Test Product in Period 2  
STARTED     13     13  
COMPLETED     13     13  
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
Participants Receiving Both Test and Reference Product Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2

Baseline Measures
    Participants Receiving Both Test and Reference Product  
Number of Participants  
[units: participants]
  26  
Age  
[units: Years]
Mean ± Standard Deviation
  29.77  ± 6.80  
Gender  
[units: Participants]
 
Female     13  
Male     13  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   AUC0-t of Rosiglitazone Maleate   [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ]

2.  Primary:   Cmax of Rosiglitazone Maleate   [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ]

3.  Primary:   AUC0-infinity of Rosiglitazone Maleate   [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ]

4.  Primary:   AUC0-t of Metformin Hydrochloride   [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ]

5.  Primary:   AUC0-infinity of Metformin Hydrochloride   [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ]

6.  Primary:   Cmax of Metformin Hydrochloride   [ Time Frame: Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2) ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01332071     History of Changes
Other Study ID Numbers: 114040
Study First Received: August 31, 2010
Results First Received: March 17, 2011
Last Updated: April 14, 2011
Health Authority: Brazil: Institutional Review Board
Brazil: ANVISA