This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
36
RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.
RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.
Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.
Simbec Research
Merthyr Tydfil, United Kingdom
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.
The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Time frame: PK Analysis 0-12hrs
Cmax - the maximum observed plasma concentration.
The Test and Reference will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Reference ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Time frame: PK Analysis 0-12hrs
AUC0-t - the area under plasma concentration curve from administration to last quantifiable concentration at time t.
The Test and Comparator will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Time frame: PK Analysis 0-12hrs
Cmax - the maximum observed plasma concentration.
The Test and Comparator will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Time frame: PK Analysis 0-12hrs
Kel - Elimination rate constant
Secondary endpoint for Test, Reference and Comparator products
Time frame: PK Analysis 0-12hrs
AUC0-inf - Area under the plasma concentration-time curve from administration to infinity
Secondary endpoint for Test, Reference and Comparator products
Time frame: PK Analysis 0-12hrs
AUCR - Ratio AUC0-t/AUC0-inf
Secondary endpoint for Test, Reference and Comparator products
Time frame: PK Analysis 0-12hrs
Tmax - Time until Cmax is first achieved
Secondary endpoint for Test, Reference and Comparator products
Time frame: PK Analysis 0-12hrs
T1/2 - Plasma concentration (elimination) half-life
Secondary endpoint for Test, Reference and Comparator products
Time frame: PK Analysis 0-12hrs
Cn - The plasma concentration at each planned nominal time point.
Secondary endpoint for Test, Reference and Comparator products
Time frame: PK Analysis 0-12hrs
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