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Completed

NCT Number: NCT06112678

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(6)

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(6).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H plus Yangji hospital

Seoul, South Korea

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.
  • Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
  • Those who meet the 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 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 ECG results at screening.
  • 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 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 and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
  • Those who donated whole blood or apheresis within 8 weeks or 4 weeks 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 criteria write below within 1 month before the first administration of investigational products.
  • Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1glass: Soju 50mL, Wine 30mL, or beer 250mL)
  • Smoking: 20 cigarettes/day
  • Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism and hypersensitive to Sunset yellow FCF.
  • 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 trial by investigators.
  • Woman who are pregnant or breastfeeding.

Treatment and study plan

CKD-348(6)

Drug

QD, PO

CKD-828, D097, D337

Drug

QD, PO

Primary outcomes

  1. AUCt of CKD-348(6)

    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(6)

    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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Phase I Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348(6) Compared With Co-administration of CKD-828, D097, and D337 in Healthy Adult Volunteers

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Mar 26, 2024

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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