Overview

Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

Status:
COMPLETED
Trial end date:
2022-08-21
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
CSPC Ouyi Pharmaceutical Co., Ltd.