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drugset / Trial / NCT04108676

Effect of Omeprazole on PK of Fluzoparib in Healthy Male Subjects

NCT04108676 ↗

Phase 1 Completed 16 enrolled Jiangsu HengRui Medicine Co., Ltd. The Third Xiangya Hospital of Central South University · collab

NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Fluzoparib in Healthy male Adults.

Timeline

Start: 2019-09-07
Primary completion: 2019-09-18
Completion: 2019-11-18

Publications

Li L, Xiang YX, Yang GP, Zhang XF, Yang XY, Yang S, Huang J. Pharmacokinetic effects of proton pump inhibitors on the novel PARP inhibitor fluzoparib: a single-arm, fixed-sequence trial in male healthy volunteers. Invest New Drugs. 2021 Jun;39(3):796-802. doi: 10.1007/s10637-020-01034-w. Epub 2021 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluzoparib	Small molecule	100 mg	Oral
Subject	Omeprazole	Other / unclassified	40 mg	Oral

Indications