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Completed

NCT Number: NCT03378284

A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

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Key information

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

  • To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.
  • To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult males aged ≥ 19 years and ≤ 50 years
  • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

Exclusion criteria

  • Presence or history of clinically significant diseases
  • Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
  • Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
  • Serologic test positive
  • Abnormal obstacle to insertion and maintenance of pH meter catheter
  • History of drug abuse
  • Excessive caffeine intake or persistent alcohol intake
  • Not use of a medically acceptable method of contraception

Treatment and study plan

Tegoprazan

Drug

Tegoprazan QD for 7 days

Revaprazan

Drug

Revaprazan QD for 7 days

Primary outcomes

  1. Gastric pH

    Time frame: up to 7 days

    Gastric pH

  2. Serum gastrin concentration

    Time frame: up to 9 days

    Serum gastrin concentration

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Randomized, Open-label, Active-controlled, Multiple Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, and Pharmacodynamics of Tegoprazan After Oral Administration in Healthy Male Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 19, 2017
Registry last updated
Mar 30, 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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