A Food Effect Study of LP-168 Tablets in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a randomized, two-period, two-sequence two-treatment crossover design food effect study to evaluate the pharmacokinetic profile of LP-168 tablets in healthy subjects after single oral administration under fasted and fed conditions

Clinical Trial Description

A total of 22 subjects from Cohort A and Cohort B, with a single sex ratio of not less than 1/3, will be included in this study. Each subject will undergo two cycles of self-crossover dosing, respectively. 4 days of PK sample collection and safety observation period will be conducted after the first dose for the first cycle, followed by the 4-day second cycle of PK sample collection and safety observation. The washout period between the 2 doses will be 7 days. Subjects who voluntarily participate in the study and complete the informed consent process will be randomly assigned to the fasted-fed group (Cohort A) or the fed-fasted group (Cohort B) in a 1:1 ratio after completion of all screening visit examinations and after the investigator determines that all inclusion criteria are met and all exclusion criteria are not met. Cohort A was administered once in Cycle 1 Day1 under fasted condition and once in Cycle 2 Day1 (i.e., Day8 after Cycle 1 administration) under fed condition for a total of 2 doses; cohort B was administered once in Cycle 1 Day 1 under fed condition and once in Cycle 2 Day 1 (i.e., D8 after Cycle 1 administration) under fasted conditions for a total of 2 doses, both at a dose of 150 mg of LP-168 tablets. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05917964
Study type	Interventional
Source	Guangzhou Lupeng Pharmaceutical Company LTD.
Contact
Status	Completed
Phase	Phase 1
Start date	June 21, 2023
Completion date	August 21, 2023

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