Pharmacokinetics and Bioequivalence of a Generic and a Branded Pazopanib Tablet in Healthy Chinese Subjects.

Abstract

This study aimed to evaluate the bioequivalence of two pazopanib tablet formulations in healthy Chinese subjects. A randomized, open-label, single-dose, two-period, two-sequence, crossover study was conducted under fasting conditions. A total of 32 eligible subjects were randomly administered a single dose of a 200-mg generic or branded pazopanib tablet with a 16-day washout period. Blood samples were collected before and up to 72hours after dosing. Pharmacokinetic parameters were analyzed with noncompartmental analysis. Safety assessments included physical examinations, laboratory tests, and adverse events reporting. Maximum plasma concentration (Cmax ), area under the plasma concentration-time curve (AUC) from zero to the last quantifiable concentration (AUC0-t ), and AUC from zero to infinity (AUC0-∞ ) were similar between the generic and branded products (all P>.05). The 90% confidence intervals of the geometric mean ratio of the test/reference products for Cmax , AUC0-t , and AUC0-∞ were 89.1%-117.1%, 81.9%-108.5%, and 82.4%-109.6%, respectively. There were no serious adverse events during the study. The newly developed generic pazopanib tablet was bioequivalent to the reference product under fasting conditions. Both formulations were well tolerated in healthy Chinese volunteers.