NCT02783638

Brief Summary

This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 16, 2019

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

February 15, 2016

Last Update Submit

January 14, 2019

Conditions

Peripheral Neuropathy Pain

Outcome Measures

Primary Outcomes (6)

  • Cohort 1: Cmax

    Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  • Cohort 1: AUCtau

    Lyrica(Pregabalin 150mg): 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  • Cohort 1: Cmax

    YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

  • Cohort 1: AUCtau

    YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

  • Cohort 2: Cmax

    YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

  • Cohort 2: AUCtau

    YHD1119(Pregabalin 300mg): 1,2,3,4,5,6,8,10,12,16,24,36 hours

Study Arms (2)

YHD1119 (Pregabalin 300mg)

EXPERIMENTAL

YHD1119 (Pregabalin 300mg)

Drug: YHD1119

Lyrica (Pregabalin 150mg)

ACTIVE COMPARATOR

Lyrica (Pregabalin 150mg)

Drug: Lyrica

Interventions

YHD1119DRUG

2 by 2

Also known as: Pregabalin 300mg
YHD1119 (Pregabalin 300mg)
LyricaDRUG

2 by 2

Also known as: Pregabalin 150mg
Lyrica (Pregabalin 150mg)

Eligibility Criteria

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

You may qualify if:

  • Healthy male with body mass index (BMI) between 18.5 and 28 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

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

February 15, 2016

First Posted

May 26, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

September 1, 2016

Last Updated

January 16, 2019

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)