A Study to Assess the Effect of HRS-1301 on the Pharmacokinetics of Midazolam and Atorvastatin in Healthy Participants
NCT07608705 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-05-27
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.
Conditions
- Hyperlipidemias
Interventions
- DRUG
-
HRS-1301 Tablets
HRS-1301 tablets.
- DRUG
-
Atorvastatin Calcium Tablets
Atorvastatin Calcium tablets.
- DRUG
-
Midazolam oral solution
Midazolam oral solution.
Sponsors & Collaborators
-
Shandong Suncadia Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- China
Study Locations
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