Health TrialsbyHealthPanel

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

ConditionsOverweight SubjectHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

111 Participants
are divided into 1 treatment group
Group A: experimental armExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

AUC[0-∞]

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

Time frame
through study completion, an average of 11 weeks
2

Cmax

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

Time frame
through study completion, an average of 11 weeks
3

AUC[0-t]

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

Time frame
through study completion, an average of 11 weeks

Secondary outcomes

1

PK parameter of HDM1002

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

Time frame
through study completion, an average of 11 weeks
2

other PK parameters

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

Time frame
through study completion, an average of 11 weeks
3

Adverse events (AEs)

Number of subjects reporting AEs

Time frame
through study completion, an average of 11 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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