NCT03191136

Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers

A Open-label, Randomized, Single Dose, Crossover Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers. Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.

Detailed description

This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers. Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8. Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.

Conditions

• Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	YHD1119 300mg	Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition
DRUG	YHD1119 300mg	Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition

Timeline

• Start date: 2017-05-10
• Primary completion: 2017-06-27
• Completion: 2017-10-30
• First posted: 2017-06-19
• Last updated: 2019-01-16

Locations

1 site across 1 country: South Korea