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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Administered orally
Single dose; Administered orally
Single dose; Administered orally
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
RECRUITINGAUC[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
Cmax
PK parameter of metformin, empagliflozin, midazolam, valsartan, and warfarin: Maximum observed concentration
Time frame: through study completion, an average of 11 weeks
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
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
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
Adverse events (AEs)
Number of subjects reporting AEs
Time frame: through study completion, an average of 11 weeks
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Single dose; Administered orally
Single dose; Administered orally
Administered orally