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OpenTrials
Completed

NCT Number: NCT04150172

To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers

This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.

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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects who give consent to voluntary participation by signing the informed consent form
  • Healthy adult males aged ≥19 and ≤45 years at screening
  • Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0

Exclusion criteria

  • Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
  • Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
  • Subjects who have participated in other clinical trial and received any other investigational products within 3 months before the expected date of IP administration
  • Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
  • Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
  • Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
  • Smokers who have smoked >10 cigarettes per day within the last 6 months
  • Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and venereal disease research laboratory (VDRL) tests

Treatment and study plan

Rebamipide SR 150mg

Drug

Test drug

Rebamipide IR 100mg

Drug

Reference Drug

Primary outcomes

  1. Cmax

    Time frame: From Period1/ Day1 to Period2/Day9

    Peak Plasma Concentration of Rebamipide

  2. AUClast of Rebamipide

    Time frame: From Period1/ Day1 to Period2/Day9

    Area Under the plasma concentration versus time curve last of Rebamipide

Secondary outcomes

  1. t1/2 β of Rebamipide

    Time frame: From Period1/ Day1 to Period2/Day9

    Time taken for half the initial dose of Rebamipide administered to be eliminated from the body

  2. Tmax of Rebamipide

    Time frame: From Period1/ Day1 to Period2/Day9

    Time at which the Cmax of Rebamipide is observed

  3. AUCinf of Rebamipide

    Time frame: From Period1/ Day1 to Period2/Day9

    Area Under the plasma concentration versus time curve inifinite of Rebamipide

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open Label, Multiple Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between "Rebamipide Sustained Release (SR) 150mg" and "Rebamipide Immediate Release (IR) 100mg" in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2019
Registry last updated
Nov 4, 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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