- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849287
Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults
February 21, 2019 updated by: Chong Kun Dang Pharmaceutical
An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetic Characteristics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D090 in Healthy Male Adults
The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D090 in healthy male adults
Study Type
Interventional
Enrollment (Anticipated)
36
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 Contact
- Name: Seunghun Han, Ph.D.
- Phone Number: +82-2-2258-7326
- Email: waystolove@catholic.ac.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul Saint Mary's Hospital
-
Contact:
- Seunghun Han, Ph.D.
- Phone Number: +82-2-2258-7326
-
-
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
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male adults aged 19 to 45 years
- Body weight more than 50kg and within ideal body weight ±20%
- signed informed consent form
Exclusion Criteria:
- Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
- Have a gastrointestinal disease history that can effect drug absorption or surgery
- Systolic Blood pressure≥140mmHg or Systolic Blood pressure<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure<60mmHg
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: Group 1
|
Test drug
Test drug
Reference Drug
|
Experimental: Group 2
|
Test drug
Test drug
Reference Drug
|
Experimental: Group 3
|
Test drug
Test drug
Reference Drug
|
Experimental: Group 4
|
Test drug
Test drug
Reference Drug
|
Experimental: Group 5
|
Test drug
Test drug
Reference Drug
|
Experimental: Group 6
|
Test drug
Test drug
Reference Drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUClast of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve to last concentration of Candesartan
|
0 hour ~ 72 hour after drug administration
|
AUClast of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve to last concentration of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
AUClast of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve to last concentration of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Cmax of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Maximum plasma concentration of Candesartan
|
0 hour ~ 72 hour after drug administration
|
Cmax of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Maximum plasma concentration of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
Cmax of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Maximum plasma concentration of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCinf of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan
|
0 hour ~ 72 hour after drug administration
|
AUCinf of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
AUCinf of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
AUCinf of 2-hydroxy atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Tmax of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Time to maximum plasma concentration of Candesartan
|
0 hour ~ 72 hour after drug administration
|
Tmax of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Time to maximum plasma concentration of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
Tmax of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Time to maximum plasma concentration of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Tmax of 2-hydroxy atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Time to maximum plasma concentration of 2-hydroxy atorvastatin
|
0 hour ~ 72 hour after drug administration
|
T1/2 of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Half-life of Candesartan
|
0 hour ~ 72 hour after drug administration
|
T1/2 of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Half-life of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
T1/2 of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Half-life of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
T1/2 of 2-hydroxy atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Half-life of 2-hydroxy atorvastatin
|
0 hour ~ 72 hour after drug administration
|
clearance of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent clearance of Candesartan
|
0 hour ~ 72 hour after drug administration
|
clearance of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent clearance of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
clearance of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent clearance of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
clearance of 2-hydroxy atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent clearance of 2-hydroxy atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Vd/F of Candesartan
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent volume of distribution of Candesartan
|
0 hour ~ 72 hour after drug administration
|
Vd/F of Amlodipine
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent volume of distribution of Amlodipine
|
0 hour ~ 72 hour after drug administration
|
Vd/F of Atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent volume of distribution of Atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Vd/F of 2-hydroxy atorvastatin
Time Frame: 0 hour ~ 72 hour after drug administration
|
Apparent volume of distribution of 2-hydroxy atorvastatin
|
0 hour ~ 72 hour after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seunghun Han, Ph.D., Department of Clinical Pharmacology, Seoul ST.Mary's Hospital
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 (Anticipated)
February 25, 2019
Primary Completion (Anticipated)
March 29, 2019
Study Completion (Anticipated)
April 6, 2019
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
February 20, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170PK18039
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
product manufactured in and exported from the U.S.
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.
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