Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants
brief summary
The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition. The secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.
detailed description
This study will be an open-label, single-dose, three-period study in healthy adult participants. A total of at least 10 participants (about half men and half women) will be will be enrolled and needed to complete in the study. Participants enrolled in this study wil be administered with Y-4 tablets, pregabalin capsules and riluzole tablets at three periods with a 7-day washout.
Periods and corresponding treatments are planned as following:
Period 1: Y-4 tablet, one tablet, 112.5 mg/28.125 mg (pregabalin/riluzole) Period 2: pregabalin capsule, one capsule, 75 mg/capsule Period 3: riluzole tablet, one tablet, 50 mg/tablet
official title
An Open-label, Single-dose, Three-period Phase Ⅰ Study to Compare the Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants