NCT01420913

Brief Summary

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule. YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation. Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
Last Updated

August 22, 2011

Status Verified

August 1, 2011

Enrollment Period

Same day

First QC Date

August 17, 2011

Last Update Submit

August 19, 2011

Conditions

Healthy

Keywords

To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C

Outcome Measures

Primary Outcomes (3)

  • Cmax,ss

    36 hr

  • AUCtau

    36 hr

  • Safety monitoring

    Laboratory findings Adverse event

    14 days

Secondary Outcomes (4)

  • AUClast AUCinfinity Tmax,ss t1/2

    36 hour

  • AUCinfinity

    36 hr

  • Tmax,ss

    36 hr

  • t 1/2

    36 hr

Study Arms (4)

Lyrica capsule(Pregabalin 150mg)

ACTIVE COMPARATOR
Drug: Pregabalin

YHD1119 A(Pregabalin SR 300mg)

EXPERIMENTAL
Drug: Pregabalin

YHD1119 B(Pregabalin SR 300mg)

EXPERIMENTAL
Drug: Pregabalin

YHD1119 C(Pregabalin SR 300mg)

EXPERIMENTAL
Drug: Pregabalin

Interventions

PregabalinDRUG

Pregabalin 300mg a day

Lyrica capsule(Pregabalin 150mg)YHD1119 A(Pregabalin SR 300mg)YHD1119 B(Pregabalin SR 300mg)YHD1119 C(Pregabalin SR 300mg)

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \~45 years old, healthy adult male subject
  • \>55 Kg(Body weight) and \< ideal body weight ± 20%

You may not qualify if:

  • AST or ALT \> 1.25 \* Upper normal range (Lab)
  • Total bilirubin \> 1.5 \* Upper normal range
  • Systolic BP \>140 OR \<100, Diastolic BP \>90 OR \<65

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul ST.Mary Hospital

Seoul, 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
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 22, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 22, 2011

Record last verified: 2011-08

Locations

KR(1)