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A Drug-drug Interaction Study Of Fluzoparib (SHR3162) on Patients With Recurrent Ovarian Cancer

NCT04718740 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-08-14

No results posted yet for this study

Summary

Primary objective: To evaluate the pharmacokinetic effects of fluzoparib on caffeine, S-warfarin, omeprazole, midazolam, repaglinide and bupropion in patients with recurrent ovarian cancer.

Secondary objective: To evaluate the safety of single dose of fluzoparib, caffeine, S-warfarin, omeprazole, midazolam, repaglinide and bupropion or fluzoparib in combination with caffeine, S-warfarin, omeprazole, midazolam, repaglinide and bupropion in patients with recurrent ovarian cancer.

Conditions

  • Recurrent Ovarian Cancer

Interventions

DRUG

fluzoparib

Group A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jing Wang, Ph.D. · Hunan Cancer Hospitol

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2022-10-26
Completion
2023-07-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718740 on ClinicalTrials.gov