The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC74647PA Capsule in Healthy Adult Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Capsule administered orally once daily
Matching Placebo Capsule
The First Hospital of Jilin University
Changchun, Jilin, China
Adverse events of the single ascending-dose
To assess the tolerability after a single dose of HEC74647PA capsule
Time frame: Baseline to day 6~13
Adverse events of the multiple ascending-dose
To assess the tolerability after multiple doses of HEC74647PA capsule
Time frame: Baseline to day 12
Tmax
Time of the maximum observed plasma concentration
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
AUC
Area under the plasma concentration-time curve (AUC)
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Cmax
Maximum observed plasma concentration of HEC74647
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
T1/2
Terminal elimination half-life
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
Vz/F
Apparent volume of distribution
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
CL/F
Oral clearance
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MRT
Mean Residence Time
Time frame: Prior to dosing (0 h) and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 h after dosing