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

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

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:

  1. Healthy male adults aged 19 to 45 years
  2. Body weight more than 50kg and within ideal body weight ±20%
  3. signed informed consent form

Exclusion Criteria:

  1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
  2. Have a gastrointestinal disease history that can effect drug absorption or surgery
  3. 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
  • Period 1: CKD-333, formula I
  • Period 2: CKD-333, formula II
  • Period 3: CKD-330, D090
Test drug
Test drug
Reference Drug
Experimental: Group 2
  • Period 1: CKD-333, formula I
  • Period 2: CKD-330, D090
  • Period 3: CKD-333, formula II
Test drug
Test drug
Reference Drug
Experimental: Group 3
  • Period 1: CKD-333, formula II
  • Period 2: CKD-330, D090
  • Period 3: CKD-333, formula I
Test drug
Test drug
Reference Drug
Experimental: Group 4
  • Period 1: CKD-333, formula II
  • Period 2: CKD-333, formula I
  • Period 3: CKD-330, D090
Test drug
Test drug
Reference Drug
Experimental: Group 5
  • Period 1: CKD-330, D090
  • Period 2: CKD-333, formula I
  • Period 3: CKD-333, formula II
Test drug
Test drug
Reference Drug
Experimental: Group 6
  • Period 1: CKD-330, D090
  • Period 2: CKD-333, formula II
  • Period 3: CKD-333, formula I
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.

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

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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