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Completed

NCT Number: NCT04768673

A Study to Investigate the PK and Safety of CKD-393

A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, Seodaemun-gu,, 03722, South Korea

About this study

A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

Who can participate

Healthy volunteers accepted: Yes

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

[Inclusion Criteria]

  • Between 19 aged and 50 aged healthy adult
  • Body weight more than 55kg for male, more than 50kg for female
  • Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
  • if female, the subject must satisfy more than one of the following:
  • subject who have reached menopause (no natural menstruation for at least 2 years.)
  • subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)

[Exclusion Criteria]

  • Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
  • Subject with one of the following laboratory test results
  • AST, ALT > UNLx1.5
  • eGRF < 60 ml/min/1.73 m2 (MDRD formula)
  • immuno-serology test results in positive
  • Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg
  • Subject who has history of the following and the history may affect safety of the subject or result of this study
  • History of any prescription drug or herbal medicine within 14 days before first administration investigational products
  • History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
  • History of drug-metabolizing induction/inhibition enzyme such as barbital

Treatment and study plan

CKD-393 formulation I

Drug

single, oral administration of 2 tablets under fed condition

CKD-393 formulation II

Drug

single, oral administration of 2 tablets under fed condition

D501, D759, H053

Drug

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

Primary outcomes

  1. Cmax

    Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Maximum concentration of drug in plasma

  2. AUClast

    Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Area under the plasma drug concentration-time curve to last concentration

Secondary outcomes

  1. AUCinf

    Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Area under the plasma drug concentration-time curve from 0 to infinity

  2. Tmax

    Time frame: 0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Time to maximum plasma concentration

  3. t1/2

    Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Terminal elimination half-life

  4. Vd/F

    Time frame: 0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Apparent Volume of Distribution

  5. CL/F

    Time frame: 0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

    Apparent Clearance

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2021
Registry last updated
Aug 2, 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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