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NOT YET RECRUITING
NCT07608705
PHASE1

A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants

Sponsor: Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.

Official title: An Open-label, Single-arm, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HRS-1301 Tablets on the Pharmacokinetics of Midazolam and Atorvastatin Calcium Tablets in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2026-06

Completion Date

2026-08

Last Updated

2026-05-27

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HRS-1301 Tablets

HRS-1301 tablets.

DRUG

Atorvastatin Calcium Tablets

Atorvastatin Calcium tablets.

DRUG

Midazolam oral solution

Midazolam oral solution.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China