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NCT Number: NCT04258865

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

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias 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 randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

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-year-old
  • Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
  • Those who are eligible for adequate 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 chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
  • Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
  • Those who agree to contraception during the participation of clinical trial
  • Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion criteria

  • Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
  • Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
  • Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
  • Those who has a history of gastrointestinal surgery (
  • Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
  • Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
  • Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  • Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
  • Women who are pregnant or who may be pregnant and breastfeed

Treatment and study plan

CKD-348 F1

Drug

QD, PO

CKD-348 F2

Drug

QD, PO

CKD-828, D097, D337

Drug

QD, PO

Primary outcomes

  1. AUCt of CKD-348

    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: 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: 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: 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: 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: 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

Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers

Acronym: CKD-348

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Jun 5, 2020

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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