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

NCT ID: NCT04150172

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-22
• Study Completion Date: 2019-05-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sequence A (RT)

[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.

Group Type: OTHER

Rebamipide SR 150mg

Intervention Type: DRUG

Test drug

Rebamipide IR 100mg

Intervention Type: DRUG

Reference Drug

Sequence B (TR)

[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.

Group Type: OTHER

Rebamipide SR 150mg

Intervention Type: DRUG

Test drug

Rebamipide IR 100mg

Intervention Type: DRUG

Reference Drug

Interventions

Rebamipide SR 150mg

Test drug

Intervention Type: DRUG

Rebamipide IR 100mg

Reference Drug

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

037-402-00035

Identifier Type: -

Identifier Source: org_study_id