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NCT Number: NCT07331389

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
  • Age range of 18-45 years old (including range), no limit to gender.
  • Subject weighed ≥50.0 kg, and a body mass index (BMI) within the range of 24.0 - 35.0 kg/m2 (including cut-off values).

Exclusion criteria

  • Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
  • History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
  • History of acute cholecystitis attack within 3 months prior to screening.
  • Severe hypoglycemic events or recurrent hypoglycemic events occurred within 3 months prior to screening
  • Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
  • Any pre-existing conditions that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, and active pathological bleeding, etc
  • History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.
  • During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .
  • Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.
  • History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.
  • Presence of clinically significant ECG results judged by the investigator at screening.

Treatment and study plan

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

Primary outcomes

  1. AUC[0-∞]

    Time frame: through study completion, an average of 11 weeks

    PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin:Area under the curve from time 0 hour to ∞

  2. Cmax

    Time frame: through study completion, an average of 11 weeks

    PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration

  3. AUC[0-t]

    Time frame: through study completion, an average of 11 weeks

    PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Area under the curve from time 0 to t hour

Secondary outcomes

  1. PK parameter of HDM1002

    Time frame: through study completion, an average of 11 weeks

    PK parameter of HDM1002 including Tmax, T1/2, CL/F, Vz/F, MRT, etc

  2. other PK parameters

    Time frame: through study completion, an average of 11 weeks

    Other PK parameters of metformin, empagliflozin, midazolam, valsartan, warfarin: Tmax, T1/2, CL/F, Vz/F, MRT, etc

  3. Adverse events (AEs)

    Time frame: through study completion, an average of 11 weeks

    Number of subjects reporting AEs

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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