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

Phase 1

Completed

• Conditions: Peripheral Neuropathic Pain
• Interventions: Drug: YHD1119 300mg

• Registration Number: NCT03191136
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2017-05-24
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Primary Completion: 2017-06-27
• Study Completion: 2017-10-30
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group1	YHD1119 300mg	taking YHD1119 (pregabalin 300mg) in fasted state at Period 1
Group2	YHD1119 300mg	taking YHD1119 (pregabalin 300mg) in fed state at Period 1

Primary Outcome Measures

Name	Time	Method
YHD1119 AUC last	0 - 36hrs	AUC last
YHD1119 Cmax	0 - 36hrs	Cmax

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of