The study will be divided into 2 parts. The first part is a relative bioavailability study of HA121-28 tablet A and HA121-28 tablet B, and the second part is a food effect study of HA121-28 tablet B. Both Parts are single-dose, randomized, open-label, two-period crossover study to evaluate relative bioavailability HA121-28 tablet B in healthy subjects and the effect of food on pharmacokinetic profile of HA121-28 tablet B, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
HA121-28 tablet B 200 mg
HA121-28 tablet A 200 mg
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf).
AUCinf (unit: ng\*h/mL)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf)
Time frame: predose (0)~288 hours post-dose
Pharmacokinetics (PK) of HA121-28 in plasma: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast).
AUC0-last(unit: ng\*h/mL)=Area under the plasma concentration time-curve from zero to the last measured concentration
Time frame: predose (0)~288 hours post-dose.
Pharmacokinetics (PK) of HA121-28 in plasma: Maximum concentration (Cmax)
Cmax(ng/mL)=Maximum concentration
Time frame: predose (0)~288 hours post-dose.
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered an IP, whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.
Time frame: up to Day 51.
Number of participants with laboratory value abnormalities and/or adverse events (AEs) .
Number of participants with potentially clinically significant laboratory values.
Time frame: up to Day 51.
Number of participants with vital sign abnormalities and/or adverse events (AEs) .
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Number of participants with potentially clinically significant vital sign values.
Time frame: up to Day 51.
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) .
Number of participants with potentially clinically significant electrocardiogram (ECG) values.
Time frame: up to Day 51 .