NCT02783183

Brief Summary

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 16, 2019

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

May 23, 2016

Last Update Submit

January 14, 2019

Conditions

Peripheral Nueropathy Pain

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss

    0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  • AUCtau

    0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary Outcomes (3)

  • AUClast,ss

    0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  • AUCinf,ss

    0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  • Tmax,ss

    0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Study Arms (2)

YHD1119

EXPERIMENTAL

Pregabalin 300mg

Drug: YHD1119Drug: Lyrica

Lyrica

ACTIVE COMPARATOR

Pregabalin 150mg

Drug: YHD1119Drug: Lyrica

Interventions

YHD1119DRUG

2 by 2

Also known as: Pregabalin 300mg
LyricaYHD1119
LyricaDRUG

2 by 2

Also known as: Pregabalin 150mg
LyricaYHD1119

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \~50 years old, healthy male volunteers
  • \>55Kg(Body weight) and 18.5\<BMI\<28

You may not qualify if:

  • AST or ALT \> 3 \* Upper normal range (Lab)
  • Total bilirubin \> 2.0 mg/dl
  • Systolic BP \>140 OR \<90, Diastolic BP \>100 OR \<60

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

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 23, 2016

First Posted

May 26, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

January 16, 2019

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share