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

Phase 1CompletedNCT03191136

Yuhan Corporation24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Neuropathic Pain

Interventions

YHD1119 300mgDRUG

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

YHD1119 300mgDRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chonbuk National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

YHD1119 Cmax

Cmax

Time frame: 0 - 36hrs

YHD1119 AUC last

AUC last

Time frame: 0 - 36hrs

Data from ClinicalTrials.gov

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