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Completed

NCT Number: NCT03444402

A Study to Compare PK and Safety of CKD-381 and D026 in Healthy Male Subjects

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul University Hospital

Seoul, South Korea

About this study

A randomized, open-label, multiple-dose, and three-way cross over clinical trial to compare pharmacokinetics and safety of CKD-381 and D026 in healthy male subjects

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 in healthy male adult
  • Body weight more than 55kg
  • Body Mass Index more than 18.5 and under 25

Exclusion criteria

  • Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
  • Have a gastrointestinal disease history that can effect drug absorption or surgery.
  • Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

Treatment and study plan

CKD-381(formulation I)

Drug

1 tablet administered before the breakfast during 7 days

CKD-381(formulation II)

Drug

1 tablet administered before the breakfast during 7 days

D026(Nexium 40mg)

Drug

1 tablet administered before the breakfast during 7 days

Primary outcomes

  1. AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

Secondary outcomes

  1. Cmax,ss(Maximum concentration of drug in plasma at steady state)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

  2. Tmax,ss(Time to maximum plasma concentration at steady state)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

  3. t1/2(Terminal elimination half-life)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

  4. R(Accumulation ratio)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

  5. CLss/F(Apparent Clearance at steady state)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

  6. Vss/F(Apparent Volume of distribution at steady state)

    Time frame: 0~24h

    Evaluation PK esomeprazole after multiple dose

  7. Cmax(Maximum concentration of drug in plasma)

    Time frame: 0~24h

    Evaluation PK esomeprazole after single dose

  8. AUClast(Area under the plasma drug concentration-time curve from 0 to last)

    Time frame: 0~24h

    Evaluation PK esomeprazole after single dose

  9. Tmax(Time to maximum plasma concentration)

    Time frame: 0~24h

    Evaluation PK esomeprazole after single dose

  10. t1/2(Terminal elimination half-life)

    Time frame: 0~24h

    Evaluation PK esomeprazole after single dose

  11. CL/F(Apparent clearance)

    Time frame: 0~24h

    Evaluation PK esomeprazole after single dose

  12. Vd/F(Apparent volume of distribution)

    Time frame: 0~24h

    Evaluation PK esomeprazole after single dose

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, and Three-way Crossover Clinical Trial to Compare Pharmacokinetics and Safety of CKD-381 and D026 in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
May 24, 2018

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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