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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Single dose; Administered orally
Single dose; Administered orally
Single dose; Administered orally
Peking University Third Hospital
Beijing, China
AUC[0-∞]
Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞
Time frame: Period 1 and Period 3: Day 1-Day 16
AUC[0-t]
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour
Time frame: Period 1 and Period 3: Day 1-Day 16
Cmax
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration
Time frame: Period 1 and Period 3: Day 1-Day 16
Tmax
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration
Time frame: Period 1 and Period 3: Day 1-Day 16
t1/2
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life
Time frame: Period 1 and Period 3: Day 1-Day 16
CL/F
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance
Time frame: Period 1 and Period 3: Day 1-Day 16
Vz/F
PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution
Time frame: Period 1 and Period 3: Day 1-Day 16
Adverse events (AEs)
Number of subjects reporting AEs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single dose; Administered orally
Administered orally
Time frame: Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35