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A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg

Primary Purpose

Hypertension and Dyslipidemia

Status
Not yet recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-386(5)
D013, D326, 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 - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adult volunteers aged ≥ 19 years Weight ≥55kg 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 have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs) Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a 4 weeks. 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) Heavy Smoking: 20 cigarettes/day Patients with the following diseases Patients with hypersensitivity to the main constituents or components of the investigational drug Severe hepatic impairment, biliary atresia or cholestasis Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists Diabetes mellitus Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2] Renal vascular hypertension patients Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit Patients with myopathy or have a history of family or genetic history of myopathy Hypothyroidism If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs 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.

Sites / Locations

  • H plus Yangji hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386(5)- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3tablets under fasting condition Period 4: CKD-386(5)- A single oral dose of 1 tablet under fasting condition

Period 1: CKD-386(5)- A single oral dose of 1 tablet under fasting condition Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386(5)- A single oral dose of 1 tablet under fasting condition Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition

Outcomes

Primary Outcome Measures

AUCt of CKD-386(5)
Area under the concentration-time curve from time zero to time
Cmax of CKD-386(5)
Maximum plasma concentration of the drug

Secondary Outcome Measures

Full Information

First Posted
January 16, 2023
Last Updated
January 16, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05698043
Brief Title
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg
Official Title
An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and the Tolerability of CKD-386(5) With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 5, 2023 (Anticipated)
Primary Completion Date
June 19, 2023 (Anticipated)
Study Completion Date
June 25, 2023 (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-386(5)
Detailed Description
An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and the tolerability of CKD-386(5) with co-administration of D013, D326, 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
Crossover 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: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-386(5)- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3tablets under fasting condition Period 4: CKD-386(5)- A single oral dose of 1 tablet under fasting condition
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: CKD-386(5)- A single oral dose of 1 tablet under fasting condition Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 3: CKD-386(5)- A single oral dose of 1 tablet under fasting condition Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition
Intervention Type
Drug
Intervention Name(s)
CKD-386(5)
Intervention Description
Test
Intervention Type
Drug
Intervention Name(s)
D013, D326, D337
Intervention Description
Reference
Primary Outcome Measure Information:
Title
AUCt of CKD-386(5)
Description
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, 6, 8, 10, 12, 24, 48, 72 hours
Title
Cmax of CKD-386(5)
Description
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, 6, 8, 10, 12, 24, 48, 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult volunteers aged ≥ 19 years Weight ≥55kg 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 have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs) Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a 4 weeks. 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) Heavy Smoking: 20 cigarettes/day Patients with the following diseases Patients with hypersensitivity to the main constituents or components of the investigational drug Severe hepatic impairment, biliary atresia or cholestasis Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists Diabetes mellitus Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2] Renal vascular hypertension patients Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit Patients with myopathy or have a history of family or genetic history of myopathy Hypothyroidism If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs 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
Jaewoo Kim, M.D.
Phone
+82-70-4665-9193
Email
m3116@newyjh.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaewoo Jaewoo, M.D.
Organizational Affiliation
H Plus Yangji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
H plus Yangji hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaewoo Kim, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg

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