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A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(2)

Primary Purpose

Hypertension and Dyslipidemia

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-348(2)
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 and Dyslipidemia

Eligibility Criteria

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

Inclusion Criteria:

  1. Healthy adult volunteers aged ≥ 19 years
  2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2

  3. Those who meet the 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 diseases or chronic diseases and have no abnormal symptoms or findings.
  5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
  6. Those who agree to contraception during the participation of clinical trial.
  7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

  1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
  2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
  3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
  4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

  5. Those who exceed an alcohol and cigarette consumption than below criteria

    • Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
    • Smoking: 20 cigarettes/day
  6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
  7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
  8. Those who are deemed insufficient to participate in this clinical study by investigators.
  9. Woman who are pregnant or breastfeeding.

Sites / Locations

  • H Plus Yangji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-348(2) - A single oral dose of 1 tablet under fasting condition

Period 1: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition

Outcomes

Primary Outcome Measures

AUCt of CKD-348(2)
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-348(2)
Cmax: Maximum plasma concentration of the drug

Secondary Outcome Measures

AUCinf of CKD-348(2)
AUCinf: Area under the concentration-time curve from zero up to ∞
Tmax of CKD-348(2)
Tmax: Time to maximum plasma concentration
AUCt/AUCinf of CKD-348(2)
AUCt/AUCinf
T1/2 of CKD-348(2)
T1/2: Terminal elimination half-life

Full Information

First Posted
April 29, 2021
Last Updated
May 11, 2021
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04883658
Brief Title
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(2)
Official Title
An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348(2) With Coadministration of CKD-828, D097 and D337 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
July 26, 2021 (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

5. Study Description

Brief Summary
A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348(2)
Detailed Description
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348(2) with coadministration of CKD-828, D097 and D337 in healthy adult volunteers

6. Conditions and Keywords

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

7. Study Design

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

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 condition Period 2: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 3: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-348(2) - A single oral dose of 1 tablet under fasting condition
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 2: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-348(2) - A single oral dose of 1 tablet under fasting condition Period 4: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition
Intervention Type
Drug
Intervention Name(s)
CKD-348(2)
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(2)
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(2)
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(2)
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(2)
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
AUCt/AUCinf of CKD-348(2)
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
Title
T1/2 of CKD-348(2)
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

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 years Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2 Those who meet the 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 diseases or chronic diseases and have no abnormal symptoms or findings. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening. Those who agree to contraception during the participation of clinical trial. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial. Exclusion Criteria: Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. Those who exceed an alcohol and cigarette consumption than below criteria Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) Smoking: 20 cigarettes/day Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Those who are deemed insufficient to participate in this clinical study by investigators. Woman who are pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yook-Hwan Noh, M.D., PhD.
Phone
82-70-4665-9174
Email
m3191@newyjh.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yook-Hwan Noh, M.D., PhD.
Organizational Affiliation
Hplus 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yook-Hwan Noh, M.D., PhD.
Phone
82-70-4665-9174
Email
m3191@newyjh.com

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(2)

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