NCT04272502

Brief Summary

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2019

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

June 4, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 10, 2020

Last Update Submit

February 13, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Maximum plasma concentration of the drug

    0 hour ~ 144 hour

  • AUCt

    Area under the concentration-time curve from time zero to time

    0 hour ~ 144 hour

Study Arms (3)

Sequence A

EXPERIMENTAL

CKD-828, D326, D337, CKD-F1, CKD-F2

Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Sequence B

EXPERIMENTAL

CKD-828, D326, D337, CKD-F1, CKD-F2

Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Sequence C

EXPERIMENTAL

CKD-828, D326, D337, CKD-F1, CKD-F2

Drug: CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Interventions

CKD-348 F1, CKD-348 F2, CKD-828, D326, D337DRUG

Each arm has a different order for taking IP

Sequence ASequence BSequence C

Eligibility Criteria

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

You may qualify if:

  • ≤ age ≤ 45
  • Health Volunteers
  • Subject who agreeds to participate in this clinical trial voluntarily

You may not qualify if:

  • \. Subject who cannot participate in a clinical trial based on the PI's judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, 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

February 10, 2020

First Posted

February 17, 2020

Study Start

June 4, 2019

Primary Completion

August 26, 2019

Study Completion

August 26, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)