NCT04939779

Trial to Evaluate Bioequivalence of LCB01-0371 in Different Batches

A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of "LCB01-0371(Batch#1650006)" and "LCB01-0371(Batch#3183817R)" in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch# 1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)	Oral administration
DRUG	LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)	Oral administration

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-01-24
• Completion: 2021-02-01
• First posted: 2021-06-25
• Last updated: 2021-06-25

Locations

1 site across 1 country: South Korea