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.
Healthy male or female aged 18 to 55 years (both inclusive).
Participants with a body mass index (BMI, weight [kg]/height2 [m2]) within 19-28 kg/m2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female.
Participants with good physical condition, without any history of disease or clinically relevantly abnormal vital signs or physical examination. Participants in good general health, without clinically significant physical examination, vital signs, laboratory tests, ECGs, or abdominal ultrasound findings at Screening or Check-in (Day -2) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
Participants with childbearing potential must agree to use adequate contraception and have no plan for pregnancy from screening period throughout 3 months after the last dose of investigational product; Women of childbearing potential (WOCBP) must have a negative blood pregnancy test prior to the first dose of investigational products. Note: WOCBP are defined as females who have reached menarche but have not yet undergone menopause (defined as ≥12 consecutive months of amenorrhea for non-pathological reasons) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
Participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage.
Participants with positive for human immunodeficiency virus (HIV) antibody test; active infection with Hepatitis B, C; positive treponema pallidum antibody test.
Participants with a history of chronic or severe diseases involving the cardiovascular, hepatic, renal, gall biliary, respiratory, hematologic/lymphatic, endocrine, immune, psychiatric, neuromuscular, or GI systems from one year prior to the first dose of study drug; or with a history (or a current condition) of GI disorders during this period, such as chronic or active upper GI diseases (e.g., esophageal disorders, gastritis, duodenitis, peptic ulcers), active GI bleeding, or history of GI surgery, as determined by the Investigator, may impact the ability of the subject to participate or potentially confound the study results.
Participants who have received a radiation dose exceeding 5 mSv within the past 12 months (e.g., more than 2 cranial CT scans [approximately 2 mSv per scan], more than 3 low-dose chest CT scans [approximately 1.5 mSv per scan], more than 1 standard chest CT scan [4-7 mSv per scan], or more than 1 abdominal CT scan [8 mSv per scan]), or have received a total radiation dose over 10 mSv in the preceding 5 years, or are scheduled to undergo additional radiological examinations during the trial or within one year after the completion of the trial.
Crossover
T25-Fast
DrugParticipants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state
Mycapssa
DrugParticipants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state
T25-Fed
DrugParticipants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state
bioavailability
The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)
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.
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)
bioavailability
The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax
PK profile (Tlag)
the first observation with a measurable (non-zero) concentration (Tlag)
PK profile(Tmax)
time to reach maximum plasma concentration
PK profile(t₁/₂)
elimination half-life (t₁/₂)
PK profile(Kel)
elimination rate constant
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Triastek (Shanghai) Limited
Lead sponsor
Zibo Central Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
