A Study to Investigate the Effect of Food on the Pharmacokinetics of HSG4112

Summary

1. Study Objective: The objective of this clinical trial is to investigate the effect of food on the pharmacokinetics of HSG4112 after oral administration in healthy male subjects. 2. Study Design and Plan: This study is a randomized, open-label, single dose, 3-way crossover clinical trial. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. A total of 12 subjects will be randomized to 6 different sequence groups. Each subject will receive a single dose of HSG4112 480 mg via oral administration under fasted, low-fat diet, and high-fat diet conditions, with a washout period of 21 days in between each dosing.

Timeline

Start

2020-07-12

Primary completion

2021-02-10

Completion

2021-02-10

Drugs

Indications