Overview

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

Status:
Completed
Trial end date:
2017-10-30
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yuhan Corporation
Criteria
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