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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03191136

Enrollment

Registered

2017-06-19

Start date

2017-05-10

Completion date

2017-10-30

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathic Pain

Brief 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.

Interventions

DRUGYHD1119 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A randomized, open-label, single dose, cross-over clincial trial

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
YHD1119 Cmax	0 - 36hrs	Cmax
YHD1119 AUC last	0 - 36hrs	AUC last

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026