Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers
February 13, 2020 updated by: Chong Kun Dang Pharmaceutical
Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-348 in Healthy Adult Volunteers
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gyeonggi-do, Korea, Republic of
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 19 ≤ age ≤ 45
- Health Volunteers
- Subject who agreeds to participate in this clinical trial voluntarily
Exclusion Criteria:
1. Subject who cannot participate in a clinical trial based on the PI's judgment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence A
CKD-828, D326, D337, CKD-F1, CKD-F2
|
Each arm has a different order for taking IP
|
|
Experimental: Sequence B
CKD-828, D326, D337, CKD-F1, CKD-F2
|
Each arm has a different order for taking IP
|
|
Experimental: Sequence C
CKD-828, D326, D337, CKD-F1, CKD-F2
|
Each arm has a different order for taking IP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cmax
Time Frame: 0 hour ~ 144 hour
|
Maximum plasma concentration of the drug
|
0 hour ~ 144 hour
|
|
AUCt
Time Frame: 0 hour ~ 144 hour
|
Area under the concentration-time curve from time zero to time
|
0 hour ~ 144 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2019
Primary Completion (Actual)
August 26, 2019
Study Completion (Actual)
August 26, 2019
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 13, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- A86_02BE1902P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.