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Study to Evaluate the Safety and Pharmacokinetics of CKD-331

Primary Purpose

Hypertension and Dyslipidemia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-331
EX5619
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:

  1. Healthy adult volunteers aged ≥ 19 years
  2. Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
  3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
  4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
  5. Those who agree to contraception during the participation of clinical trial.
  6. 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 have no medical history of disgetive disease, cardiovasular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, imunological disease, otolaryngological disease, dermatological disease, ophatological disease
  2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
  3. 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.
  4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
  5. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.

  6. 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
  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 hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence A

Sequence B

Arm Description

Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition

Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 4: EX5619 - A single oral dose of 1 tablet under fasting condition

Outcomes

Primary Outcome Measures

Cmax of CKD-331
Cmax: Maximum plasma concentration of the drug
AUCt of CKD-331
AUCt: Area under the concentration-time curve from time zero to time

Secondary Outcome Measures

Full Information

First Posted
April 12, 2022
Last Updated
June 7, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05335044
Brief Title
Study to Evaluate the Safety and Pharmacokinetics of CKD-331
Official Title
An Open-label, Randomized, Single-dose, 2-sequence, 4-period, Cross-over, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
July 12, 2022 (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
Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers
Detailed Description
An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 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
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 4: EX5619 - A single oral dose of 1 tablet under fasting condition
Intervention Type
Drug
Intervention Name(s)
CKD-331
Intervention Description
QD, PO
Intervention Type
Drug
Intervention Name(s)
EX5619
Intervention Description
QD, PO
Primary Outcome Measure Information:
Title
Cmax of CKD-331
Description
Cmax: Maximum plasma concentration of the drug
Time Frame
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours
Title
AUCt of CKD-331
Description
AUCt: Area under the concentration-time curve from time zero to time
Time Frame
Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 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 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 have no medical history of digestive disease, cardiovascular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, immunological disease, otolaryngological disease, dermatological disease, ophiological disease Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 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 received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaewoo Kim, M.D., PhD.
Organizational Affiliation
Yanhji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
H plus Yangji hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety and Pharmacokinetics of CKD-331

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