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Completed

NCT Number: NCT03738449

The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D484 under fed condition in healthy adults.

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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, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 19 to 55 years
  • Females must be menopause or surgical infertility
  • Signed informed consent form
  • Other inclusion criteria, as defined in the protocol

Exclusion criteria

  • History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
  • Clinical laboratory test values are outside the accepted normal range at Screening
  • aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range
  • Total Bilirubin > 1.5 times the upper limit of the normal range
  • creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range
  • estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)
  • Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
  • systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg
  • Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
  • Participated in a clinical trial within 90 days prior to 1st IP dosing
  • Not eligible to participate for the study at the discretion of Investigator
  • Other exclusive inclusion criteria, as defined in the protocol

Treatment and study plan

CKD-387

Drug

Test drug

D484

Drug

reference drug

Primary outcomes

  1. Maximum plasma concentration of Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Cmax of Metformin

  2. Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration

    Time frame: 0 hour ~ 48 hour after drug administration

    AUClast of Metformin

Secondary outcomes

  1. Area under the plasma concentration of Metformin-time curve from time zero to infinity

    Time frame: 0 hour ~ 48 hour after drug administration

    AUCinf of Metformin

  2. Time to reach maximum (peak) plasma concentration of Metformin following drug administration

    Time frame: 0 hour ~ 48 hour after drug administration

    Tmax of Metformin

  3. Half-life of Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    t1/2 of Metformin

  4. Apparent clearance of Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    CL/F of Metformin

  5. Apparent volume of distribution of Metformin

    Time frame: 0 hour ~ 48 hour after drug administration

    Vd/F of Metformin

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/Tolerability After Oral Administration of CKD-387 and D484 Under Fed Condition in Healthy Adults

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2018
Registry last updated
Feb 21, 2019

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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