This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
A generic product manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.
Olaparib Tablet reference formulation 100mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cmax Description: Maximum observed plasma concentration
Cmax Description: Maximum observed plasma concentration
Time frame: Up to 72 hours post-dose for each period
AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time
AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time
Time frame: Up to 72 hours post-dose for each period
AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
Time frame: Up to 72 hours post-dose for each period
Time of maximum observed plasma concentration (Tmax)
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 72 hours post-dose for each period
Terminal elimination half-life (T1/2)
Terminal elimination half-life (T1/2)
Time frame: Up to 72 hours post-dose for each period
Apparent total body clearance (Cl/F)
Apparent total body clearance (Cl/F)
Time frame: Up to 72 hours post-dose for each period
Apparent volume of distribution (V/F)
Apparent volume of distribution (V/F)
Time frame: Up to 72 hours post-dose for eachperiod
Number of participants with Adverse Events
Number of participants with Adverse Events
Time frame: Up to 10 days
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