Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects - Trial NCT06360445
Access comprehensive clinical trial information for NCT06360445 through Pure Global AI's free database. This Phase 1 trial is sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. and is currently Completed. The study focuses on Healthy Participants. Target enrollment is 102 participants.
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Study Focus
Sponsor & Location
CSPC Ouyi Pharmaceutical Co., Ltd.
Timeline & Enrollment
Phase 1
May 26, 2022
Aug 21, 2022
Primary Outcome
Cmax Description: Maximum observed plasma concentration,AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time,AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06360445
Non-Device Trial