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