The DDI Study Had Been Designed to Investigate the Effect of SHR3680 on the Pharmacokinetics of Midazolam, S-Warfarin and Omeprazole

NCT04676035 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-09

No results posted yet for this study

Summary

The DDI study had been designed to investigate the effect of SHR3680 on the pharmacokinetics of Midazolam, S-Warfarin and Omeprazole

Conditions

  • Prostate Cancer Patients

Interventions

DRUG

Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680

* Experimental: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680 * Midazolam, Warfarin, Omeprazole and VitaminK1 QD on Day 1 and Day 22, SHR3680 240 mg once daily (QD) from Study Day 6 - 27

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-01-26
Completion
2022-01-26

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 NCT04676035 on ClinicalTrials.gov