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NCT Number: NCT03191136

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

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.

Completed

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Key information

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHD1119 300mg

Drug

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

Primary outcomes

  1. YHD1119 Cmax

    Time frame: 0 - 36hrs

    Cmax

  2. YHD1119 AUC last

    Time frame: 0 - 36hrs

    AUC last

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2017
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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