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A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348

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ClinicalTrials.gov Identifier: NCT05549401
Recruitment Status : Not yet recruiting
First Posted : September 22, 2022
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348.

Condition or disease Intervention/treatment Phase
Hypertension and Dyslipidemia Drug: CKD-348(4) F1 Drug: CKD-348(4) F2 Drug: CKD-828, D097, D337 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348 With Co-administration of CKD-828, D097, and D337 in Healthy Adult Volunteers
Estimated Study Start Date : September 23, 2022
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 6, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition
Drug: CKD-348(4) F1
QD, PQ

Drug: CKD-348(4) F2
QD, PQ

Drug: CKD-828, D097, D337
QD, PQ

Experimental: Sequence 2
Period 1: CKD-828, D097, D337- A single oral dose of 3 tablets under fasting condition Period 2: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition
Drug: CKD-348(4) F1
QD, PQ

Drug: CKD-348(4) F2
QD, PQ

Drug: CKD-828, D097, D337
QD, PQ

Experimental: Sequence 3
Period 1: CKD-348(4) F1 - 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(4) F2 - A single oral dose of 1 tablet under fasting condition
Drug: CKD-348(4) F1
QD, PQ

Drug: CKD-348(4) F2
QD, PQ

Drug: CKD-828, D097, D337
QD, PQ

Experimental: Sequence 4
Period 1: CKD-348(4) F1 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F2 - 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
Drug: CKD-348(4) F1
QD, PQ

Drug: CKD-348(4) F2
QD, PQ

Drug: CKD-828, D097, D337
QD, PQ

Experimental: Sequence 5
Period 1: CKD-348(4) F2 - 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(4) F1 - A single oral dose of 1 tablet under fasting condition
Drug: CKD-348(4) F1
QD, PQ

Drug: CKD-348(4) F2
QD, PQ

Drug: CKD-828, D097, D337
QD, PQ

Experimental: Sequence 6
Period 1: CKD-348(4) F2 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-348(4) F1 - 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
Drug: CKD-348(4) F1
QD, PQ

Drug: CKD-348(4) F2
QD, PQ

Drug: CKD-828, D097, D337
QD, PQ




Primary Outcome Measures :
  1. AUCt of CKD-348(4) F1 and CKD-348(4) F2 [ 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 ]
    AUCt: Area under the concentration-time curve from time zero to time

  2. Cmax of CKD-348(4) F1 and CKD-348(4) F2 [ 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 ]
    Maximum plasma concentration of the drug



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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 1ECG 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 and those who take drug could affect to clinical trial within 10 days 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 criteria write below within 1 month before the first administration of investigational products.

    • 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 trial by investigators.
  9. Woman who are pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05549401


Contacts
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Contact: Jaewoo Kim, M.D. Ph.D +82 70 4665 9193 m3116@newyjh.com

Locations
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Korea, Republic of
H plus Yangji hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Jaewoo Kim, M.D. Ph.D m3116@newyjh.com
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT05549401    
Other Study ID Numbers: A86_11BE2218P
First Posted: September 22, 2022    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases