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Effect of Omeprazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

NCT04989829 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-08

No results posted yet for this study

Summary

This is a one-arm, fixed-sequence study to compare the pharmacokinetic profiles of SHR6390 in absence and presence of prior administration of proton pump inhibitor Omeprazole. The increased gastric pH achieved by the treatment with multiple doses of Omeprazole might affect the absorption process of SHR6390.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

SHR6390、Omeprazole

SHR6390 tablet single dose、Omeprazol 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
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-27
Primary Completion
2022-01-26
Completion
2022-02-14

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 NCT04989829 on ClinicalTrials.gov