NCT03822065

A Relative Bioavailability Food Effect Study of LY03005

A Randomized, Open-Label, 2-Period, Crossover Trial to Assess the Relative Bioavailability of 80 mg LY03005 After Single Dose Administration to Healthy Subjects Under Fed Versus Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial.

Detailed description

Thirty-two (32) eligible healthy subjects between ages of 18-50 years old will be enrolled and randomized to either Sequence 1 (fed to fasted state) versus Sequence 2 (fasted to fed state) at a 1:1 ratio.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	LY03005	80 mg oral tablet single dose

Timeline

• Start date: 2019-01-16
• Primary completion: 2019-02-16
• Completion: 2019-02-16
• First posted: 2019-01-30
• Last updated: 2019-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study