Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants

Part of paid clinical trials in Secaucus, New Jersey.

Sponsor
Neurodawn Pharmaceutical Co., Ltd.
Study ID
NCT07618715
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy Male and Female Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Y-4 tablet — DRUG
    Participants will be admitted to research center on Day-1. Participants are required to fast for at least 10 hours prior to dosing on Day 1. In the morning of Day 1, participants will be administered with one tablet of Y-4 (pregabalin 112.5 mg and riluzole 28.125 mg), then participants will be monitored and blood samples will be collected for the following 72 hours (Day4).
  • Pregabalin capsule — DRUG
    Participants are required to fast for at least 10 hours prior to dosing on Day 8. In the morning of Day 8, participants will be administered with one pregabalin capsule (75 mg pregabalin), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 11).
  • Riluzole tablet — DRUG
    Participants are required to fast for at least 10 hours prior to dosing on Day 15. In the morning of Day 15, participants will be administered with one riluzole tablet (50 mg riluzole), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 18).

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
11 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Y-4 tables
    In the morning of Day 1 ，single oral administration one Y-4 tablet in the state of fasting state.
  • Experimental: Pregabalin capsule
    In the morning of Day 8 ，single oral administration one pregabalin capsule in the state of fasting state.
  • Experimental: Riluzole tablet
    In the morning of Day 15 ，single oral administration one riluzole tablet in the state of fasting state.

Primary Outcome Measure

Cmax [ Time Frame: On Day1-4、Day8-11、Day15-18 of observation period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Frontage Clinical Services,Inc.SecaucusNew Jersey07094
Frank Lee
[email protected]
(201)416-7753

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By research site
Frontage Clinical Services,Inc.· Secaucus, NJ

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