Back to resultsClinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
Primary Purpose
Peripheral Neuropathic Pain
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YHD1119 300mg
YHD1119 300mg
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathic Pain
Eligibility 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
Sites / Locations
- Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group1
Group2
Arm Description
taking YHD1119 (pregabalin 300mg) in fasted state at Period 1
taking YHD1119 (pregabalin 300mg) in fed state at Period 1
Outcomes
Primary Outcome Measures
YHD1119 Cmax
Cmax
YHD1119 AUC last
AUC last
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03191136
Brief Title
Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
A randomized, open-label, single dose, cross-over clincial trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group1
Arm Type
Experimental
Arm Description
taking YHD1119 (pregabalin 300mg) in fasted state at Period 1
Arm Title
Group2
Arm Type
Experimental
Arm Description
taking YHD1119 (pregabalin 300mg) in fed state at Period 1
Intervention Type
Drug
Intervention Name(s)
YHD1119 300mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
YHD1119 300mg
Intervention Description
Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition
Primary Outcome Measure Information:
Title
YHD1119 Cmax
Description
Cmax
Time Frame
0 - 36hrs
Title
YHD1119 AUC last
Description
AUC last
Time Frame
0 - 36hrs
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingul Kim, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
561-712
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34256964
Citation
Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.
Results Reference
derived
Learn more about this trial
Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
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