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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2019-07-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Rebamipide SR 150mg after high-fat meal

Intervention Type DRUG

Test Drug

Rebamipide SR 150mg under fasting condition

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 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.

Group Type OTHER

Rebamipide SR 150mg after high-fat meal

Intervention Type DRUG

Test Drug

Rebamipide SR 150mg under fasting condition

Intervention Type DRUG

Reference Drug

Interventions

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Rebamipide SR 150mg after high-fat meal

Test Drug

Intervention Type DRUG

Rebamipide SR 150mg under fasting condition

Reference Drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes