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NCT Number: NCT04587206

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

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348

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Key information

Conditions

Hypertension and Dyslipidemia Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Gwanak-gu, 08779, South Korea

About this study

A Phase 1 Clinical Trial to evaluate the tolerability and pharmacokinetics in healthy adult volunteers after administration of CKD-348 and co-administration of CKD-828, D097, D337.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

A. Systolic Blood Pressure: 90 to 139 mmHg B. 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 2 months or 1 month 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 A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. 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.

Treatment and study plan

CKD-348

Drug

QD, PO

CKD-828, D097, D337

Drug

QD, PO

Primary outcomes

  1. AUCt of CKD-348

    Time frame: [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

    Time frame: [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]

    Cmax: Maximum plasma concentration of the drug

Secondary outcomes

  1. AUCinf of CKD-348

    Time frame: [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]

    AUCinf: Area under the concentration-time curve from zero up to ∞

  2. Tmax of CKD-348

    Time frame: [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]

    Tmax: Time to maximum plasma concentration

  3. T1/2 of CKD-348

    Time frame: [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]

    T1/2: Terminal elimination half-life

  4. AUCt/AUCinf of CKD-348

    Time frame: [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/AUCinf

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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