NCT04278391

Brief Summary

This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2019

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

Study Start

First participant enrolled

July 2, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Maximum concentration of DWJ1421

    0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h

  • AUClast

    Area under the drug concentration-time curve

    0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h

Study Arms (2)

A (RT)

EXPERIMENTAL

Period 1 : Reference drug (DWC201903) Period 2 : Test durg(DWJ1421)

Drug: DWC201903

B (TR)

EXPERIMENTAL

Period 1 : Test durg(DWJ1421) Period 2 : Reference drug (DWC201903)

Drug: DWJ1421

Interventions

DWJ1421DRUG

1 tablet administered in fasting condition

B (TR)
DWC201903DRUG

1 tablet administered in fasting condition

A (RT)

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 19 aged and 45 aged in healthy male adult
  • Body weight more than 50kg
  • Body Mass Index more than 18.0 and under 27.0

You may not qualify if:

  • Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history
  • Those who have a gastrointestinal disease history that can effect drug absorption or surgery
  • Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

Related Publications (1)

  • Shin W, Yang AY, Yun H, Cho DY, Park KH, Shin H, Kim A. Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects. Transl Clin Pharmacol. 2020 Sep;28(3):160-167. doi: 10.12793/tcp.2020.28.e13. Epub 2020 Sep 21.

    PMID: 33062629DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

July 2, 2019

Primary Completion

August 10, 2019

Study Completion

February 19, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)