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

Healthy Participants Clinical Trial

Official title:
A Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06360445
Study type Interventional
Source CSPC Ouyi Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 26, 2022
Completion date August 21, 2022
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