NCT02538003

To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371

A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Effect of Food on the Pharmacokinetics of LCB01-0371 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.

Detailed description

A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LCB01-0371 Tablet 800 mg(R)	Reference: taken drug before meal
DRUG	LCB01-0371 Tablet 800 mg(T)	Test: taken drug after meal

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-02
• Last updated: 2016-03-23

Locations

1 site across 1 country: South Korea