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

Yuhan

Status and phase

Completed

Phase 1

Conditions

Peripheral Neuropathic Pain

Treatments

Drug: YHD1119 300mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03191136

YHD1119-104

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
Who has not suffered from clinically significant disease
Provision of signed written informed consent

Exclusion criteria

History of and clinically significant disease
A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
Administration of other investigational products within 3 months prior to the first dosing
Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs