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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04150172

Enrollment

Registered

2019-11-04

Start date

2019-04-22

Completion date

2019-05-10

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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.

Interventions

DRUGRebamipide SR 150mg

Test drug

DRUGRebamipide IR 100mg

Reference Drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Subjects who give consent to voluntary participation by signing the informed consent form 2. Healthy adult males aged ≥19 and ≤45 years at screening 3. Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0

Exclusion criteria

1. Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity 2. Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP 3. Subjects who have participated in other clinical trial and received any other investigational products within 3 months before the expected date of IP administration 4. Subjects who have taken any inducers or inhibitors of drug metabolism enzyme 5. Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug 6. 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 7. Smokers who have smoked \>10 cigarettes per day within the last 6 months 8. Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and venereal disease research laboratory (VDRL) tests

Design outcomes

Primary

Measure	Time frame	Description
Cmax	From Period1/ Day1 to Period2/Day9	Peak Plasma Concentration of Rebamipide
AUClast of Rebamipide	From Period1/ Day1 to Period2/Day9	Area Under the plasma concentration versus time curve last of Rebamipide

Secondary

Measure	Time frame	Description
t1/2 β of Rebamipide	From Period1/ Day1 to Period2/Day9	Time taken for half the initial dose of Rebamipide administered to be eliminated from the body
Tmax of Rebamipide	From Period1/ Day1 to Period2/Day9	Time at which the Cmax of Rebamipide is observed
AUCinf of Rebamipide	From Period1/ Day1 to Period2/Day9	Area Under the plasma concentration versus time curve inifinite of Rebamipide

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026