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Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

Primary Purpose

Hypertension, Dyslipidemias

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-333, formula I
CKD-333, formula II
CKD-330, D090
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul Saint Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Arm Description

Period 1: CKD-333, formula I Period 2: CKD-333, formula II Period 3: CKD-330, D090

Period 1: CKD-333, formula I Period 2: CKD-330, D090 Period 3: CKD-333, formula II

Period 1: CKD-333, formula II Period 2: CKD-330, D090 Period 3: CKD-333, formula I

Period 1: CKD-333, formula II Period 2: CKD-333, formula I Period 3: CKD-330, D090

Period 1: CKD-330, D090 Period 2: CKD-333, formula I Period 3: CKD-333, formula II

Period 1: CKD-330, D090 Period 2: CKD-333, formula II Period 3: CKD-333, formula I

Outcomes

Primary Outcome Measures

AUClast of Candesartan
Area under the plasma concentration-time curve to last concentration of Candesartan
AUClast of Amlodipine
Area under the plasma concentration-time curve to last concentration of Amlodipine
AUClast of Atorvastatin
Area under the plasma concentration-time curve to last concentration of Atorvastatin
Cmax of Candesartan
Maximum plasma concentration of Candesartan
Cmax of Amlodipine
Maximum plasma concentration of Amlodipine
Cmax of Atorvastatin
Maximum plasma concentration of Atorvastatin

Secondary Outcome Measures

AUCinf of Candesartan
Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan
AUCinf of Amlodipine
Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine
AUCinf of Atorvastatin
Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin
AUCinf of 2-hydroxy atorvastatin
Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin
Tmax of Candesartan
Time to maximum plasma concentration of Candesartan
Tmax of Amlodipine
Time to maximum plasma concentration of Amlodipine
Tmax of Atorvastatin
Time to maximum plasma concentration of Atorvastatin
Tmax of 2-hydroxy atorvastatin
Time to maximum plasma concentration of 2-hydroxy atorvastatin
T1/2 of Candesartan
Half-life of Candesartan
T1/2 of Amlodipine
Half-life of Amlodipine
T1/2 of Atorvastatin
Half-life of Atorvastatin
T1/2 of 2-hydroxy atorvastatin
Half-life of 2-hydroxy atorvastatin
clearance of Candesartan
Apparent clearance of Candesartan
clearance of Amlodipine
Apparent clearance of Amlodipine
clearance of Atorvastatin
Apparent clearance of Atorvastatin
clearance of 2-hydroxy atorvastatin
Apparent clearance of 2-hydroxy atorvastatin
Vd/F of Candesartan
Apparent volume of distribution of Candesartan
Vd/F of Amlodipine
Apparent volume of distribution of Amlodipine
Vd/F of Atorvastatin
Apparent volume of distribution of Atorvastatin
Vd/F of 2-hydroxy atorvastatin
Apparent volume of distribution of 2-hydroxy atorvastatin

Full Information

First Posted
February 20, 2019
Last Updated
February 21, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03849287
Brief Title
Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults
Official Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2019 (Anticipated)
Primary Completion Date
March 29, 2019 (Anticipated)
Study Completion Date
April 6, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: CKD-333, formula I Period 2: CKD-333, formula II Period 3: CKD-330, D090
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: CKD-333, formula I Period 2: CKD-330, D090 Period 3: CKD-333, formula II
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Period 1: CKD-333, formula II Period 2: CKD-330, D090 Period 3: CKD-333, formula I
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Period 1: CKD-333, formula II Period 2: CKD-333, formula I Period 3: CKD-330, D090
Arm Title
Group 5
Arm Type
Experimental
Arm Description
Period 1: CKD-330, D090 Period 2: CKD-333, formula I Period 3: CKD-333, formula II
Arm Title
Group 6
Arm Type
Experimental
Arm Description
Period 1: CKD-330, D090 Period 2: CKD-333, formula II Period 3: CKD-333, formula I
Intervention Type
Drug
Intervention Name(s)
CKD-333, formula I
Intervention Description
Test drug
Intervention Type
Drug
Intervention Name(s)
CKD-333, formula II
Intervention Description
Test drug
Intervention Type
Drug
Intervention Name(s)
CKD-330, D090
Intervention Description
Reference Drug
Primary Outcome Measure Information:
Title
AUClast of Candesartan
Description
Area under the plasma concentration-time curve to last concentration of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
AUClast of Amlodipine
Description
Area under the plasma concentration-time curve to last concentration of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
AUClast of Atorvastatin
Description
Area under the plasma concentration-time curve to last concentration of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
Cmax of Candesartan
Description
Maximum plasma concentration of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
Cmax of Amlodipine
Description
Maximum plasma concentration of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
Cmax of Atorvastatin
Description
Maximum plasma concentration of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Secondary Outcome Measure Information:
Title
AUCinf of Candesartan
Description
Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
AUCinf of Amlodipine
Description
Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
AUCinf of Atorvastatin
Description
Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
AUCinf of 2-hydroxy atorvastatin
Description
Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
Tmax of Candesartan
Description
Time to maximum plasma concentration of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
Tmax of Amlodipine
Description
Time to maximum plasma concentration of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
Tmax of Atorvastatin
Description
Time to maximum plasma concentration of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
Tmax of 2-hydroxy atorvastatin
Description
Time to maximum plasma concentration of 2-hydroxy atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
T1/2 of Candesartan
Description
Half-life of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
T1/2 of Amlodipine
Description
Half-life of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
T1/2 of Atorvastatin
Description
Half-life of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
T1/2 of 2-hydroxy atorvastatin
Description
Half-life of 2-hydroxy atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
clearance of Candesartan
Description
Apparent clearance of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
clearance of Amlodipine
Description
Apparent clearance of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
clearance of Atorvastatin
Description
Apparent clearance of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
clearance of 2-hydroxy atorvastatin
Description
Apparent clearance of 2-hydroxy atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
Vd/F of Candesartan
Description
Apparent volume of distribution of Candesartan
Time Frame
0 hour ~ 72 hour after drug administration
Title
Vd/F of Amlodipine
Description
Apparent volume of distribution of Amlodipine
Time Frame
0 hour ~ 72 hour after drug administration
Title
Vd/F of Atorvastatin
Description
Apparent volume of distribution of Atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration
Title
Vd/F of 2-hydroxy atorvastatin
Description
Apparent volume of distribution of 2-hydroxy atorvastatin
Time Frame
0 hour ~ 72 hour after drug administration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seunghun Han, Ph.D.
Phone
+82-2-2258-7326
Email
waystolove@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seunghun Han, Ph.D.
Organizational Affiliation
Department of Clinical Pharmacology, Seoul ST.Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seunghun Han, Ph.D.
Phone
+82-2-2258-7326

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

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