A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07331389
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Subjects
  • Overweight Subject

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin — DRUG
    Administered orally
  • Empagliflozin — DRUG
    Single dose; Administered orally
  • Midazolam — DRUG
    Single dose; Administered orally
  • Valsartan — DRUG
    Single dose; Administered orally
  • Warfarin — DRUG
    Single dose; Administered orally
  • HDM1002 — DRUG
    Administered orally

Study Details

The purpose of this study is to characterize the drug-drug intereaction of HDM1002 and metformin, empagliflozin, midazolam, valsartan, and warfarin in overweight/obese adult subjects. The safety and tolerability of HDM1002 with metformin, empagliflozin, midazolam, valsartan, and warfarin when given separately or together will also be evaluated

Key Dates

Start date
Sep 24, 2025
Status verified
Dec 2025
Primary completion
Jan 12, 2026
Completion
Jun 13, 2026

Study Design

Enrollment
111 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental arm
    Cohort 1 (Study on the Interaction between HDM1002 and Metformin, empagliflozin), Cohort 2 (Study on the Interaction between HDM1002 and Midazolam, valsartan, Warfarin)

Primary Outcome Measure

AUC[0-∞] [ Time Frame: through study completion, an average of 11 weeks ]

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