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Amoxicillin Bioequivalence Study Brazil - Fast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01431989
First received: September 8, 2011
Last updated: January 4, 2013
Last verified: January 2013
Results First Received: January 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Infections, Bacterial
Interventions: Drug: Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL
Drug: Amoxil® 500mg/5mL powder for oral suspension

  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
This is a prospective, open-label, randomized, crossover, single-dose study in which two different treatments (Test Product versus Reference Product) were administered in two sequences in two study periods. The objective was to confirm if two formulations of Amoxicillin trihydrate, in the form of powder for oral suspension, are bioequivalent.

Reporting Groups
  Description
Test Product in Period 1: Reference Product in Period 2 Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
Reference Product in Period 1: Test Product in Period 2 Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, 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     14     14  
COMPLETED     14     14  
NOT COMPLETED     0     0  

Period 2:   14-Day Washout Period
    Test Product in Period 1: Reference Product in Period 2     Reference Product in Period 1: Test Product in Period 2  
STARTED     14     14  
COMPLETED     14     14  
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     14     14  
COMPLETED     14     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
Participants Receiving Both Test and Reference Products Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2

Baseline Measures
    Participants Receiving Both Test and Reference Products  
Number of Participants  
[units: participants]
  28  
Age  
[units: Years]
Mean ± Standard Deviation
  34.54  ± 7.38  
Gender  
[units: Participants]
 
Female     14  
Male     14  
Race/Ethnicity, Customized  
[units: participants]
 
White     10  
Black     4  
Mulatto     14  



  Outcome Measures
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1.  Primary:   Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)   [ Time Frame: Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

2.  Primary:   Maximum Observed Concentration of Drug Through Time (Cmax)   [ Time Frame: Collection points (hrs): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

3.  Primary:   Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)   [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

4.  Primary:   Time of Maximum Observed Concentration (Tmax)   [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

5.  Primary:   Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)   [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

6.  Primary:   Terminal Half-life (T1/2_Kel)   [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]

7.  Primary:   First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)   [ Time Frame: Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study]) ]


  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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01431989     History of Changes
Other Study ID Numbers: 115954
Study First Received: September 8, 2011
Results First Received: January 5, 2012
Last Updated: January 4, 2013
Health Authority: Brazil: Institutional Review Board