Pharmacokinetics and Safety Profile of CKD-333

October 29, 2018 updated by: Chong Kun Dang Pharmaceutical

An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults

Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

Study Overview

Status

Completed

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 D086 in healthy male adults

Study Type

Interventional

Enrollment (Actual)

37

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

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. Between 19 aged and 45 aged in healthy male adult
  2. Body weight more than 50kg and within ideal body weight ±20%

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. SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<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: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
Drug: CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Names:
  • Reference drug
Experimental: Group 2
Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
Drug: CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Names:
  • Reference drug
Experimental: Group 3
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
Drug: CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Names:
  • Reference drug
Experimental: Group 4
Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
Drug: CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Names:
  • Reference drug
Experimental: Group 5
Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
Drug: CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Names:
  • Reference drug
Experimental: Group 6
Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)
Drug: CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Names:
  • Test drug
Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Names:
  • Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin
Time Frame: 0~72hours
0~72hours
Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin
Time Frame: 0~72hours
0~72hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time Frame: 0~72hours
0~72hours
Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time Frame: 0~72hours
0~72hours
t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time Frame: 0~72hours
0~72hours
CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time Frame: 0~72hours
0~72hours
Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin
Time Frame: 0~72hours
0~72hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: Seunghun Han, Ph.D., Department of Clinical Pharmacology, Seoul ST.Mayr'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 (Actual)

August 8, 2018

Primary Completion (Actual)

October 5, 2018

Study Completion (Actual)

October 12, 2018

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170PK18015

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.

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