NCT04819932

Brief Summary

Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

January 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 13, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2021

Completed
Last Updated

March 29, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

January 27, 2021

Last Update Submit

March 25, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameter of DWJ1451:AUC0-t

    Area under the plasma xonxentration-time curve from time 0 to t

    0 - 72 hours after dosing

  • Pharmacokinetic parameter of DWJ1451:Cmax

    Maximum plasma drug concentration

    0 - 72 hours after dosing

Study Arms (2)

group1

EXPERIMENTAL

subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition

Drug: DWJ1451

group2

EXPERIMENTAL

subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition

Drug: DWJ1451

Interventions

DWJ1451DRUG

DWC202008 DWC202009

group1group2

Eligibility Criteria

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

You may qualify if:

  • Age 19 to 55 years
  • Healthy Adult

You may not qualify if:

  • Non-Healthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

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

January 27, 2021

First Posted

March 29, 2021

Study Start

March 13, 2021

Primary Completion

March 13, 2021

Study Completion

April 2, 2021

Last Updated

March 29, 2021

Record last verified: 2021-01

Locations

KR(1)