NCT03733574

A Study of LY03005 vs Pristiq

A Randomized, Open-Label, 2-Treatment, 2-Sequence, 2-Period Crossover Trial to Assess the Bioequivalence of 80 mg LY03005 to 50 mg Pristiq After Single Dose Administration Under Fasting Conditions to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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

Fifty six (56) 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	Drug: LY03005 80 mg, oral tablets, single dose
DRUG	Pristiq	Drug: Pristiq 50 mg, oral tablets, single dose

Timeline

• Start date: 2018-06-19
• Primary completion: 2018-07-17
• Completion: 2018-07-26
• First posted: 2018-11-07
• Last updated: 2018-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study