NCT02988024

Pilot BA Study of New LY03005 vs Pristiq

A Randomized, Open-Label, Single-Dose Study to Assess the Relative Bioavailability of LY03005 Oral Tablets Versus Pristiq Oral Tablets Under Fasting Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objects of this study is to assess the relative bioavailability (BA) of 80 mg LY03005 oral tablets compared to 50 mg Pristiq® oral tablets after a single oral intake under fasting conditions in healthy subjects between 18 and 50 years of age.

Detailed description

Twenty (20) eligible subjects will be enrolled and assigned to either LY03005 group or Pristiq group at a 1:1 ratio at one site in the USA.

Conditions

• Major Depression

Interventions

Type	Name	Description
DRUG	LY03005	LY03005
DRUG	Pristiq

Timeline

• Start date: 2016-12-07
• Primary completion: 2016-12-28
• Completion: 2016-12-28
• First posted: 2016-12-09
• Last updated: 2017-03-20

Locations

1 site across 1 country: United States