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A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 (CKD-348)

Primary Purpose

Hypertension, Dyslipidemias

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-348 F1
CKD-348 F2
CKD-828, D097, D337
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring CKD-348

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adult volunteers aged ≥ 19-year-old
  2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
  3. Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
  4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
  5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
  6. Those who agree to contraception during the participation of clinical trial
  7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

  1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
  2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
  3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
  4. Those who has a history of gastrointestinal surgery (
  5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
  6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
  7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
  9. Women who are pregnant or who may be pregnant and breastfeed

Sites / Locations

  • H Plus Yangji 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

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions

Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions

Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions

Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions

Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions

Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions

Outcomes

Primary Outcome Measures

AUCt of CKD-348
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-348
Cmax: Maximum plasma concentration of the drug

Secondary Outcome Measures

AUCinf of CKD-348
AUCinf: Area under the concentration-time curve from zero up to ∞
Tmax of CKD-348
Tmax: Time to maximum plasma concentration
t1/2 of CKD-348
t1/2: Terminal elimination half-life
AUCt/AUCinf of CKD-348
AUCt/AUCinf

Full Information

First Posted
February 5, 2020
Last Updated
June 3, 2020
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04258865
Brief Title
A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348
Acronym
CKD-348
Official Title
Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
April 26, 2020 (Actual)
Study Completion Date
May 13, 2020 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
A clinical trial to compare the pharmacokinetics and tolerability of CKD-348
Detailed Description
A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemias
Keywords
CKD-348

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Period 1: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions Period 3: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Period 1: CKD-348 formulation 2 - A single oral dose of 1 tablet under fasting conditions Period 2: CKD-348 formulation 1 - A single oral dose of 1 tablet under fasting conditions Period 3: CKD-828, D097, D337 - A single oral dose of 3 tablets under fasting conditions
Intervention Type
Drug
Intervention Name(s)
CKD-348 F1
Intervention Description
QD, PO
Intervention Type
Drug
Intervention Name(s)
CKD-348 F2
Intervention Description
QD, PO
Intervention Type
Drug
Intervention Name(s)
CKD-828, D097, D337
Intervention Description
QD, PO
Primary Outcome Measure Information:
Title
AUCt of CKD-348
Description
AUCt: Area under the concentration-time curve from time zero to time
Time Frame
Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Title
Cmax of CKD-348
Description
Cmax: Maximum plasma concentration of the drug
Time Frame
Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary Outcome Measure Information:
Title
AUCinf of CKD-348
Description
AUCinf: Area under the concentration-time curve from zero up to ∞
Time Frame
Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Title
Tmax of CKD-348
Description
Tmax: Time to maximum plasma concentration
Time Frame
Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Title
t1/2 of CKD-348
Description
t1/2: Terminal elimination half-life
Time Frame
Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Title
AUCt/AUCinf of CKD-348
Description
AUCt/AUCinf
Time Frame
Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult volunteers aged ≥ 19-year-old Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2 Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests Those who agree to contraception during the participation of clinical trial Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial Exclusion Criteria: Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month Those who has a history of gastrointestinal surgery ( Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests Women who are pregnant or who may be pregnant and breastfeed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yook-Hwan Noh, M.D., PhD.
Organizational Affiliation
H Plus Yangji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Plus Yangji Hospital
City
Seoul
State/Province
Gwanak-gu
ZIP/Postal Code
08779
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

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