The goal of this clinical trial\] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are: 1. How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa? 2. What effects does of food have on the pharmacokinetic profile of T25 when administerted under high fat diet? Participants will: Take T25 under both fast and food state or mycapssa in under fast state in Day1, Day4, and Day7, 13. A follow-up visit is scheduled on D14+(7), which is 7\~14 days after the last dose of investigational product via phone/message/WeChat or in face-to-face manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state
Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state
Zibo Central Hospital
Zibo, Shandong, China
bioavailability
The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)
Time frame: From time 0 (administration) to 24 hours post-administration
bioavailability
The ratio of geometric least square means between the T25 and MYCAPSSA® for area under the concentration-time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast) . Sampling (Fasted condition) occurs at the following timepoints: 0 (pre-dose) , 0.5 , 1.0, 1.33 , 1.67 , 2.0 , 2.33 , 2.67 , 3.0 , 3.33 , 3.67 , 4.0 , 4.5 , 5.0 , 5.5 , 6.0 , 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose.
Time frame: From time 0 (administration) to 24 hours post-administration.
bioavailability
The ratio of geometric least square means between the T25 and MYCAPSSA® for AUC from time zero to infinity (AUC0-inf) via dose normalization. AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)
Time frame: From 0 (administration) to 24hour
bioavailability
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax
Time frame: From time 0 (administration) to 24 hours post-administration
bioavailability
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC0-tlast (sampling occurs at the following timepoints: Fasted condition: 0 (pre-dose) , 0.5 , 1.0, 1.33, 1.67, 2.0, 2.33, 2.67, 3.0, 3.33, 3.67, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose; Fed condition: 0 (pre-dose), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 , 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 , 11.0, 12.0, 14.0, 16.0, 24.0 hour post-dose;)
Time frame: From time 0 (administration) to 24 hours post-administration.
bioavailability
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC from time zero to infinity (AUC0-inf).AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)
Time frame: From time 0 (administration) to 24hour.
PK profile (Tlag)
the first observation with a measurable (non-zero) concentration (Tlag)
Time frame: From time 0 (administration) to 24 hours post-administration
PK profile(Tmax)
time to reach maximum plasma concentration
Time frame: From time 0 (administration) to 24 hours post-administration
PK profile(t₁/₂)
elimination half-life (t₁/₂)
Time frame: From time 0 (administration) to 24 hours post-administration
PK profile(Kel)
elimination rate constant
Time frame: From time 0 (administration) to 24 hours post-administration
PK profile(CL/F)
apparent total clearance after oral administration
Time frame: From time 0 (administration) to 24 hours post-administration
PK profile(Vz/F)
apparent volume of distribution after oral administration
Time frame: From time 0 (administration) to 24 hours post-administration
PK profile(AUC_%Extrap)
percentage of area under the concentration-time curve extrapolated beyond the last measurable concentration
Time frame: From time 0 (administration) to 24 hours post-administration
the gastrointestinal transit of T25 using an abdominal X-ray
the abdominal X-ray
Time frame: Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose.
the gastrointestinal transit of T25 using an abdominal X-ray
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the abdominal X-ray
Time frame: Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose.
Safety and tolerability - number and severity of adverse events
Incidence and severity of AE
Time frame: From the first dose until 7 days after the last dose
Safety and tolerability -Temperature (ear)
Incidence of Adverse Events and Abnormalities as assessed by Temperature (ear)
Time frame: From the first dose until 7 days after the last dose
Safety and tolerability - Blood pressure
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
Time frame: From the first dose until 7 days after the last dose
Safety and tolerability -Pulse
Incidence of Adverse Events and Abnormalities as assessed by pulse
Time frame: From the first dose until 7 days after the last dose
Safety and tolerability - Physical examination
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
Time frame: From the first dose until 7 days after the last dose
Safety and tolerability - clinical laboratory tests
Number of abnormalities assessed based on safety bloods and urine test( hematology, blood biochemistry, coagulation function, urinalysis, thyroid function, serum vitamin B12, serum pregnancy test (only for females), etc)
Time frame: From the first dose until 7 days after the last dose
Safety and tolerability - ECG
Heart Rate, PR Interval, QRS duration,QT Interval,QTc Interval
Time frame: From the first dose until 7 days after the last dose