Bioequivalence Clinical Trial
Official title:
An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Crossover Bioequivalence Study of Palbociclib 125 mg Capsules (Iclos) and Ibrance (Palbociclib) 125 mg Capsules Pfizer in Healthy Subjects Under Fed Condition
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition.
24 healthy subjects males and/or non pregnant, non breast feeding females will be randomized to receive either Test product (Palbociclib 125 mg Capsules of Iclos Uruguay S.A.) or Reference product (Ibrance® Palbociclib 125 mg Capsules of Pfizer Europe in healthy, adult, human subjects under fed condition. Trial design will be balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of in healthy, adult, human subjects under fed condition to assess the bioequivalence between test and comparator formulations. Statistical analysis will be performed on the Ln-transformed pharmacokinetic parameters using SAS® v 9.4. The analysis will include data from subjects who complete the study. If there are dropouts, no replacement will be done. To establish bioequivalence of the test product with that of comparator product, 90% Confidence Interval (CI) for the ratio (Test/ Comparator) of Least Square Means of the log transformed PK parameters (Cmax and AUC0-72) must fall between 80.00% and 125.00%. Confidence Interval (CI) values will not be rounded off. ;
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