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A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Drug: CKD-391, QD, PO
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring CKD-391

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2 Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: 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 Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery Patients with the following diseases Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit Patients with severe liver failure or biliary obstruction and bile congestion Patients with muscular disease, rhabdomyolysis, or persons with a past history Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs Patients with renal impairment or a history of in and patients with severe renal dysfunction Patients with a history of muscle toxicity to other statin drugs or fibrate drugs Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have hypersensitivity to the main constituents or components of the investigational drug Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests Woman who are pregnant or breastfeeding Those who are deemed insufficient to participate in clinical study by investigators

Sites / Locations

  • Bumin Hospital(Seoul)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 2: CKD-391 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 4: CKD-391 - A single oral dose of 1 tablet under fasting condition

Period 1: CKD-391 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 3: CKD-391 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition

Outcomes

Primary Outcome Measures

Primary Outcome Measure
AUCt of CKD-391: Area under the concentration-time curve time zero to time
Primary Outcome Measure
Cmax of CKD-391: Maximum plasma concentration of the drug

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
October 5, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05634447
Brief Title
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391
Official Title
A Phase I Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-391 and Co-administration of CKD-331 and D337 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
June 7, 2023 (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

5. Study Description

Brief Summary
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-391
Detailed Description
A phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after administration of CKD-391 and co-administration of CKD-331 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
Dyslipidemias
Keywords
CKD-391

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 2: CKD-391 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 4: CKD-391 - A single oral dose of 1 tablet under fasting condition
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: CKD-391 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition Period 3: CKD-391 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331, D337 - A single oral dose of 2 tablets under fasting condition
Intervention Type
Drug
Intervention Name(s)
Drug: CKD-391, QD, PO
Intervention Description
Drug: CKD-331, D337 QD, PO
Primary Outcome Measure Information:
Title
Primary Outcome Measure
Description
AUCt of CKD-391: Area under the concentration-time curve time zero to time
Time Frame
Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours
Title
Primary Outcome Measure
Description
Cmax of CKD-391: Maximum plasma concentration of the drug
Time Frame
Pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult aged between 19 to 55 at screening Weight ≥ 50kg(man) or 45kg(woman), with calculated body mass index (BMI) of 18 to 30kg/m2 Those who have no clinically significant congenital or chronic diseases and have no abnormal symptoms of findings Those who are deemed suitable for clinical trials based on laboratory (hematology, blood chemistry, serology, urinalysis, urine drug test) and 12-lead ECG results at screening Those who agree to contraception from the first IP dosing day till 14 days after the last dosing day and decide not to provide sperm during the participation of clinical trial Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial Exclusion Criteria: 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 Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 21 glasses/week(man), 14 glasses/week(woman), smoking> 20 cigarettes/day) and not able to stop on smoking, caffeine and alcohol Those who received investigational products or participated in bioequivalence test within 6 months before the first administration of clinical trial drugs Those who donated whole blood within 8 weeks before the first date of administration and donated ingredients within 2 weeks or received blood transfusion in 4 weeks Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery Patients with the following diseases Patients with active liver disease or with elevated amino transferase levels with unknown cause increased by more than 3 times the normal upper limit Patients with severe liver failure or biliary obstruction and bile congestion Patients with muscular disease, rhabdomyolysis, or persons with a past history Patients with hypothyroidism, patients with genetic muscle disease or their family history, and patients with history of muscle disability due to drugs Patients with renal impairment or a history of in and patients with severe renal dysfunction Patients with a history of muscle toxicity to other statin drugs or fibrate drugs Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Those who have hypersensitivity to the main constituents or components of the investigational drug Those who have a history of drug abuse within 1 year of screening or who have tested positive for urine drug tests Woman who are pregnant or breastfeeding Those who are deemed insufficient to participate in clinical study by investigators
Facility Information:
Facility Name
Bumin Hospital(Seoul)
City
Seoul
State/Province
Gangseo-gu
ZIP/Postal Code
07590
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-391

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