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Completed

NCT Number: NCT03863938

Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital, Clinical Trial Center

Seoul, South Korea

About this study

Primary Outcome Measure:

  • AUClast and Cmax of tegaprazan
  • Gastric pH

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
  • Helicobacter pylori negative

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 50mg

Drug

K-CAB

Other names: Tegoprazan 50mg tablet

Primary outcomes

  1. AUClast of tegaprazan

    Time frame: Pre-dose(0 hour) and up to 48 hours in each period

    Area under the plasma concentration versus time curve of tegoprazan

  2. Cmax of tegaprazan

    Time frame: Pre-dose(0 hour) and up to 48 hours in each period

    Peak Plasma Concentration of tegoprazan

  3. Gastric pH

    Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period

    Gastric pH

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Aug 22, 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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