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Completed

NCT Number: NCT03980756

A Study to Compare PK, PD and Safety of the AD-206 and Esomeprazole

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.

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Key information

Conditions

Gastritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19~50 years in healthy male volunteers
  • BMI is more than 18 kg/m^2 , no more than 27.0 kg/m^2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion criteria

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

Treatment and study plan

AD-206 20mg

Drug

1 tablet administered before the breakfast during 7 days

Other names: Test drug

Esomeprazole 20mg

Drug

1 tablet administered before the breakfast during 7 days

Other names: Reference Drug

AD-206 40mg

Drug

1 tablet administered before the breakfast during 7 days

Other names: Test drug

Esomeprazole 40mg

Drug

1 tablet administered before the breakfast during 7 days

Other names: Reference Drug

Primary outcomes

  1. AUCtau,ss(Area under the plasma drug concentration-time curve)

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

  2. Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity)

    Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring

    Evaluation PD esomeprazole after multiple dose

Secondary outcomes

  1. AUCtau(Area under the plasma drug concentration-time curve)

    Time frame: Day1

    Evaluation PK esomeprazole after single dose

  2. Cmax(Maximum concentration of drug in plasma)

    Time frame: Day1

    Evaluation PK esomeprazole after single dose

  3. Tmax(Time to maximum plasma concentration)

    Time frame: Day1

    Evaluation PK esomeprazole after single dose

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

    Time frame: Day1

    Evaluation PK esomeprazole after single dose

  5. CL/F(Apparent clearance)

    Time frame: Day1

    Evaluation PK esomeprazole after single dose

  6. Vd/F(Apparent volume of distribution)

    Time frame: Day1

    Evaluation PK esomeprazole after single dose

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

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

  8. Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma)

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

  9. Cav,ss(Average concentration of drug in plasma at steady state)

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

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

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

  11. t1/2,ss(Terminal elimination half-life at steady state)

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

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

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

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

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

  14. PTF(Peak trough fluctuation over one dosing interal at steady state)

    Time frame: From Day 1 up to Day 29

    Evaluation PK esomeprazole after multiple dose

  15. After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours

    Time frame: Day1 24hrs pH monitoring

    Evaluation PD esomeprazole

  16. After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours

    Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring

    Evaluation PD esomeprazole

  17. After the first administration and 7 days of repeated administration, The median pH measured for 24 hours

    Time frame: Day1 24hrs pH monitoring, Day7 24hrs pH monitoring

    Evaluation PD esomeprazole

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of AD-206 to Esomeprazole in Healthy Male Volunteers

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2019
Registry last updated
Jan 13, 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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