NCT03191136

CompletedPhase 1

Clinical Trial to Assess the Effect of Food on the Pharmacok...

Yuhan Corporation Source

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Other study identifiers

Sponsor study identifier

YHD1119-104

Study Type

interventional

Actual enrollment (reported)

24

Locations

1 country

Sites

1

Timeline

Study Start

May 10, 2017

Actual (reported)

Primary Completion

June 27, 2017

Actual (reported)

Study Completion

October 30, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: October 30, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 10, 2017
Actual (reported)
First Submitted
May 24, 2017
Actual (reported)
First Posted
June 19, 2017
Actual (reported)
Primary Completion
June 27, 2017
Actual (reported)
Study Completion
October 30, 2017
Actual (reported)

Last Updated: January 16, 2019
Status Verified: June 2017
Last Update Submitted: January 14, 2019

Conditions

Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

YHD1119 Cmax
Cmax
0 - 36hrs
YHD1119 AUC last
AUC last
0 - 36hrs

Study Arms (2)

Group1

EXPERIMENTAL

taking YHD1119 (pregabalin 300mg) in fasted state at Period 1

Drug: YHD1119 300mg

Group2

EXPERIMENTAL

taking YHD1119 (pregabalin 300mg) in fed state at Period 1

Drug: YHD1119 300mg

Interventions

YHD1119 300mgDrug

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

Group1Group2

YHD1119 300mgDrug

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

Eligibility Criteria

Age19 Years - 55 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsHealthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2

Sponsors & Collaborators

Yuhan Corporation
Industrylead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Related Publications (1)

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.
PMID: 34256964DERIVED

Study Officials

Mingul Kim, MD
Chonbuk National University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

June 19, 2017

Study Start

May 10, 2017

Actual (reported)

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Phase 3Completed

NCT05416931

ACD440 Gel in Peripheral Neuropathic Pain

Phase 2Completed

NCT07755514

Gabapentin and Pregabalin Effects on Inflammation and Cardiac Function in Peripheral Neuropathic Pain

Not Yet Recruiting

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NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark

Completed

Group1Group2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Who has not suffered from clinically significant disease

Provision of signed written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

June 27, 2017

Actual (reported)

Study Completion

October 30, 2017

Actual (reported)

Last Updated

January 16, 2019

Record last verified: 2017-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03191136
Data provider: ClinicalTrials.gov
Source updated: 2019-01-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:57 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Group1

Group2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations