To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT04150146
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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 6 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A (RT) Rebamipide SR 150mg under fasting condition \[Sequence A (RT) \& Sequence B (TR)\] 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. Sequence B (TR) Rebamipide SR 150mg under fasting condition \[Sequence A (RT) \& Sequence B (TR)\] 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. Sequence A (RT) Rebamipide SR 150mg after high-fat meal \[Sequence A (RT) \& Sequence B (TR)\] 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. Sequence B (TR) Rebamipide SR 150mg after high-fat meal \[Sequence A (RT) \& Sequence B (TR)\] 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method AUCinf of Rebamipide From Period1/ Day1 to Period2/Day9 Area Under the plasma concentration versus time curve inifinite of Rebamipide
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
Trial Locations
- Locations (1)
CHA Bundang Medical Center, CHA University
🇰🇷Bundang, Gyeonggi-do, Korea, Republic of