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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04150172

037-402-00035

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence A (RT)

Other group

Description:

\[Sequence A (RT) \& Sequence B (TR)\] 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.

Treatment:

Drug: Rebamipide SR 150mg

Drug: Rebamipide IR 100mg

Sequence B (TR)

Other group

Description:

\[Sequence A (RT) \& Sequence B (TR)\] 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.

Treatment:

Drug: Rebamipide SR 150mg

Drug: Rebamipide IR 100mg