Study design:

a two-period, crossover, single-dose bioequivalence study in 36 healthy volunteers of both sexes, clinical confinement during 10 hours before and 32 hours after the dose, 20 blood samples per subject per period will be collected before dosing and till 32 hours after the drug administration, at least 7 day washout between drug administrations. A validated HPLC/MS/MS method will be used for the assay of 1440 plasma samples for the pioglitazone.

Following pharmacokinetic parameters will be evaluated from the concentration-time curves after the single dose till 32 hours in 36 healthy volunteers:

AUC(0 – 72), AUC(0 – inf), Cmax, Cmax/ AUC(0 – inf), Tmax,  and t1/2e. The statistical evaluation will be performed using both  the parametric approach after the ln transformation AUC, Cmax/ AUC(0 – inf) and Cmax, and non-transformed data using ANOVA and General Linear Models (GLM) of SAS software. The power approach will include the calculation of a confidence interval for the difference between the averages of ln transformed data of the test and reference products. The confidence interval 80 – 125 % (90% probability) will be considered as significant for the decision on bioequivalence/inequivalence. The nonparametric approach will be used for Tmax and t1/2e.

Parallel to the power approach Shuirmann´s two one sided t-test procedure will be done.


The study will be performed according to the ICHGCP/GLP quidelines. Inspection of sponsor-monitor as well as of inspector of the medicinal authorities be accepted and respected so that study will correspond to the requirements of regulatory authorities in Europe.


Parallel to the power approach Shuirmann´s two one sided t-test procedure will be done.



a) for managing the study including the protocol:preparation:                             400.- EUR

b) for clinical part of the study                                                                                                  0.- EUR

c) for the assay of 1440 plasma for pioglitazone

using HPLC/MS/MS method:                                                                40, 320.- EUR

d) Incured sample reassay (ISR) of 144 samples                                          4, 030.- EUR*

d) for PK and statistical evaluation and final report:                           4, 500.- EUR*


In total:                                                                                                49, 250.- EUR

     In total without ISR:                                                                           45, 220.- EUR* 

     In total without ISR and without PK and statistics:                          40, 720.- EUR*



     Price is valid for 90 days, Reference and internal standards costs are not included.

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