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

NCT04150172 | Completed Phase 1

• 1 other identifier: 037-402-00035
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• t1/2 β of Rebamipide

  From Period1/ Day1 to Period2/Day9

• Tmax of Rebamipide

  From Period1/ Day1 to Period2/Day9

• AUCinf of Rebamipide

  From Period1/ Day1 to Period2/Day9

Study Arms (2)

Sequence A (RT)

OTHER

\[Sequence A (RT) \& Sequence B (TR)\] to receive the Investigational Product (IP) by the sequence in each period: * Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours. * Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.

Drug: Rebamipide SR 150mg; Drug: Rebamipide IR 100mg

Sequence B (TR)

OTHER

\[Sequence A (RT) \& Sequence B (TR)\] to receive the Investigational Product (IP) by the sequence in each period: * Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours. * Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.

Drug: Rebamipide SR 150mg; Drug: Rebamipide IR 100mg

Interventions

Rebamipide SR 150mg DRUG

Test drug

Sequence A (RT); Sequence B (TR)

Rebamipide IR 100mg DRUG

Reference Drug

Sequence A (RT); Sequence B (TR)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

CHA Bundang Medical Center, CHA University

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

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: November 4, 2019
• Study Start: April 22, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 10, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)