A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.
NCT06601517 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2024-09-23
Summary
The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.
Conditions
- Healthy Adult Subject
- Overweight Subject
Interventions
- DRUG
-
Repaglinide
Single dose; Administered orally
- DRUG
-
Single dose; Administered orally
- DRUG
-
Digoxin
Single dose; Administered orally
- DRUG
-
Rosuvastatin
Single dose; Administered orally
- DRUG
-
HDM1002
Administered orally
Sponsors & Collaborators
-
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-31
- Primary Completion
- 2025-02-28
- Completion
- 2025-04-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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