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Pharmacokinetics and Safety Profile of CKD-333

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659149
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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Brief Summary:
Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemias Drug: CKD-333 formulation I Drug: CKD-333 formulation II Drug: CKD-330+D086 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Test drug

Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Name: Test drug

Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Name: 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 Name: Test drug

Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Name: Test drug

Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Name: 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 Name: Test drug

Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Name: Test drug

Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Name: 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 Name: Test drug

Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Name: Test drug

Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Name: 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 Name: Test drug

Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Name: Test drug

Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Name: 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 Name: Test drug

Drug: CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
Other Name: Test drug

Drug: CKD-330+D086
2 tablet administered before the breakfast(single-dose)
Other Name: Reference drug


Outcome Measures
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Primary Outcome Measures :
  1. AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin [ Time Frame: 0~72hours ]
  2. Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin [ Time Frame: 0~72hours ]

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659149


Locations
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Korea, Republic of
Seoul Saint Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Seunghun Han, Ph.D. Department of Clinical Pharmacology, Seoul ST.Mayr's Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03659149    
Other Study ID Numbers: 170PK18015
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
Hypertension
Dyslipidemias
CKD-333
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
 Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases