To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers

A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers

This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Rebamipide SR 150mg after high-fat meal; Drug: Rebamipide SR 150mg under fasting condition

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Bundang, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 6 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sequence A (RT); [Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: • Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal.	Drug: Rebamipide SR 150mg after high-fat meal; Test Drug; Drug: Rebamipide SR 150mg under fasting condition; Reference Drug
Other: Sequence B (TR); [Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period: • Rebamipide SR 150 mg: At 9 am on 1d (8d), take with 150 mL of water under the fasting condition for ≥10 hours or after a high-fat meal.	Drug: Rebamipide SR 150mg after high-fat meal; Test Drug; Drug: Rebamipide SR 150mg under fasting condition; Reference Drug

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): July 14, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Rebamipide
• Other Study ID Numbers: 037-402-00036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No