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A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

NCT05392127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-12-22

No results posted yet for this study

Summary

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.

Conditions

Interventions

DRUG

SHR0302 Tablets

SHR0302 Tablets once daily

DRUG

Midazolam Maleate Tablets

Midazolam Maleate Tablets single dose

DRUG

Warfarin Sodium Tablets

Warfarin Sodium Tablets single dose

DRUG

Omeprazole Enteric Capsules

Omeprazole Enteric Capsules single dose

DRUG

Vitamin K1 Tablets

Vitamin K1 Tablets once daily

DRUG

Repaglinide Tablets

Repaglinide Tablets single dose

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2022-08-18
Completion
2022-08-18

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05392127 on ClinicalTrials.gov