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

NCT03191136 | Completed Phase 1

• 1 other identifier: YHD1119-104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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 300mg DRUG

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

Group1; Group2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Healthy male with body mass index (BMI) between 18.5kg/m2 and 30kg/m2
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

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: 34256964 DERIVED

Study Officials

• Mingul Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A randomized, open-label, single dose, cross-over clincial trial

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 19, 2017
• Study Start: May 10, 2017
• Primary Completion: June 27, 2017
• Study Completion: October 30, 2017
• Last Updated: January 16, 2019

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)