NCT06360445

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Olaparib Tablet test formulation 100mg	A generic product manufactured by CSPC Ouyi Pharmaceutical Co., Ltd.
DRUG	Olaparib Tablet reference formulation 100mg	Olaparib Tablet reference formulation 100mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
DRUG	Olaparib Tablet test formulation 150mg	Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.
DRUG	Olaparib Tablet reference formulation 150mg	Olaparib Tablet reference formulation 150mg were used as a comparator drug for the bioequivalence study, manufactured by AbbVie Limited.

Timeline

• Start date: 2022-05-26
• Primary completion: 2022-08-21
• Completion: 2022-08-21
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: China