NCT03357796

Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®

A Randomized, Open-label, Cross-over, 2-period Study to Assess the Relative Bioavailability Between 80 mg LY03005 Versus 50 mg Desvenlafaxine Comparator (Pristiq®) Under Fasting Condition After Single Dose Administration 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 objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in healthy subjects between 18 and 50 years of age.

Detailed description

Twenty (20) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	LY03005	80 mg, oral tablets, single dose
DRUG	Pristiq	50 mg, oral tablets, single dose

Timeline

• Start date: 2017-11-27
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2017-11-30
• Last updated: 2018-01-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study