Main study objective: the pharmacokinetic effects of high-fat diet on AL8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects. Secondary study objectives: safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects
This is a Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects. Sixteen healthy subjects were randomly divided into two sequence groups, a and B, and eight subjects in each sequence group were dosed according to either the fasting → postprandial or the postprandial → fasting sequence. The washout period was 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Sequence A group: on the 1st day, take a single dose of AL8326 tablets on an empty stomach. On the 15th day, take a single dose of AL8326 tablets after meals. Sequence B group: on the 1st day after meal, take a single dose of AL8326 tablets; on the 15th day, take a single dose of AL8326 tablets on an empty stomach.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGAUC0-t
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Time frame: 120 hours after each dose
AUC0-∞
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Time frame: 120 hours after each dose
Cmax
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Time frame: 120 hours after each dose
Tmax
Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
Time frame: 120 hours after each dose
T1/2
Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
Time frame: 120 hours after each dose
Incidence of adverse events / serious adverse events as well as severity
Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
Time frame: Day 15 (± 1) after the last Administration
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