NCT03261427

Brief Summary

The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2017

Typical duration for phase_1 healthy

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

First Submitted

Initial submission to the registry

August 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

September 14, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

27 days

First QC Date

August 22, 2017

Last Update Submit

July 8, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Part I : AUClast of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part I : Cmax of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part II : AUCτ,ss of Pregabalin

    Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part II : Cmax,ss of Pregabalin

    Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Secondary Outcomes (13)

  • Part I : AUCinf of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part I : Tmax of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part I : t1/2 of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part I : Vd/F of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • Part I : CL/F of Pregabalin

    0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  • +8 more secondary outcomes

Study Arms (2)

YNP-1807 Tablet(Pregabalin 330mg)

EXPERIMENTAL

YNP-1807(Pregabalin 330mg), QD

Drug: YNP-1807 330Mg Tablet

Lyrica Capsule(Pregabalin 150mg)

ACTIVE COMPARATOR

Lyrica Capsule(Pregabalin 150mg), BID

Drug: Lyrica 150Mg Capsule

Interventions

Lyrica 150Mg CapsuleDRUG

150 mg oral administered (BID)

Lyrica Capsule(Pregabalin 150mg)
YNP-1807 330Mg TabletDRUG

330 mg oral administered (QD)

YNP-1807 Tablet(Pregabalin 330mg)

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years to 55 years healthy volunteers adult at screening visit
  • For male, weight is more than 55 kg, for female, weight is more than 50 kg.
  • Body mass index(BMI) value : 18.5 to 25.0 kg/m2
  • If female, should be included one at least as following
  • menopausal(menstruation for 2 years minimum)
  • surgery infertility

You may not qualify if:

  • Any history of drug overdose or dependence
  • Female who is pregnant or nursing
  • AST, ALT \> ULN\*1.25
  • Total bilirubin \> ULN\*1.5
  • CPK \> ULN\*1.5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Yonsei-ro Seodaemun-gu, 120-752, South Korea

Location

MeSH Terms

Interventions

PregabalinTablets

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsDosage FormsPharmaceutical Preparations

Study Officials

  • MinSoo Park, MD,PhD

    Severance Hospital, Seoul, Korea

    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

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 25, 2017

Study Start

September 14, 2017

Primary Completion

October 11, 2017

Study Completion

March 29, 2018

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

KR(1)