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

No results posted yet for this study

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

Atorvastatin

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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Entities

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 NCT06601517 on ClinicalTrials.gov