The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.
This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B. Group A:In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD). Group B:In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
60mg QD
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Pharmacokinetics (PK) profile: Cmax
Peak Plasma Concentration
Time frame: up to 13 Days
Pharmacokinetics (PK) profile: Tmax
Time to reach the maximum plasma concentration
Time frame: up to 13 Days
Pharmacokinetics (PK) profile: T1/2
Terminal half-life
Time frame: up to 13 Days
Pharmacokinetics (PK) profile: AUC
Area under the single-dose plasma concentration-time curve
Time frame: up to 13 Days
material balance
Drug recovery
Time frame: up to 13 Days
Adverse events (AEs)
Incidence of treatment-related AEs
Time frame: up to 43 Days
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