Parexel International Los Angeles Early Phase Clinical Unit
Glendale, California, 91206, United States
NCT Number: NCT05940883
This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive one Y-2 sublingual tablet sublingually once daily for Day1 and Day 19 and twice daily for Day 6 to Day 18.
Placebo, sublingually, single and multiple ascending dosing in group 1 and 2 subjects.
Time frame: Until follow-up(Day26)or early termination
To evaluate the safety and tolerability following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.
Time frame: Day1,Day2, Day6,Day7,Day11,Day12
To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.
Time frame: Day1,Day2, Day6,Day7,Day11,Day12
To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.
Time frame: Day1,Day2, Day6,Day7,Day11,Day12
To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.
Time frame: Day1,Day2, Day6,Day7,Day11,Day12
To evaluate the effects of different administration conditions on the PK of edaravone and dexborneol in plasma following single administration of Y-2 sublingual tablet in healthy adult subjects in part 2.
Time frame: Day1,Day2,Day6 and Day18 to Day20
To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.
Time frame: Day1,Day2,Day6 and Day18 to Day20
To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.
Time frame: Day1,Day2,Day6 and Day18 to Day20
To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.
Time frame: Day1,Day2,Day6 and Day18 to Day20
To characterize the PK of edaravone and dexborneol in plasma following single and multiple administrations of Y-2 sublingual tablet in healthy adult subjects in part 1.
Time frame: Until follow-up(Day18)or early termination
To evaluate the safety following different single administration conditions of Y-2 sublingual tablet in healthy adult subjects in part 2.
Simcere Pharmaceutical Co., Ltd
Other
A 2-Part, Randomized, Phase I Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details