Y-4 Tablets with Pregabalin and Riluzole for Healthy Participants
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for healthy adults in the U.S. who do not have any major health problems. Participants should not be taking other medications or have conditions that could affect drug absorption or safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single oral administration of Y-4 tablet in a fasting state
Washout Period 1
7-day washout period between treatments
Treatment Period 2
Participants receive a single oral administration of pregabalin capsule in a fasting state
Washout Period 2
7-day washout period between treatments
Treatment Period 3
Participants receive a single oral administration of riluzole tablet in a fasting state
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares how the body processes a new tablet called Y-4 with two existing drugs, pregabalin and riluzole, after a single dose taken on an empty stomach. The trial also checks if these medicines are safe and well-tolerated.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
In the morning of Day 1 ，single oral administration one Y-4 tablet in the state of fasting state.
In the morning of Day 15 ，single oral administration one riluzole tablet in the state of fasting state.
In the morning of Day 8 ，single oral administration one pregabalin capsule in the state of fasting state.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurodawn Pharmaceutical Co., Ltd.
Lead Sponsor
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