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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Open Label, Multiple Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between "Rebamipide Sustained Release (SR) 150mg" and "Rebamipide Immediate Release (IR) 100mg" in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150172
• Other study ID #: 037-402-00035
• Status: Completed
• Phase: Phase 1
• Start date: April 22, 2019
• Est. completion date: May 10, 2019

Study information

• Verified date: September 2019
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 10, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Rebamipide SR 150mg
Test drug
• Rebamipide IR 100mg
Reference Drug

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Peak Plasma Concentration of Rebamipide	From Period1/ Day1 to Period2/Day9
Primary	AUClast of Rebamipide	Area Under the plasma concentration versus time curve last of Rebamipide	From Period1/ Day1 to Period2/Day9
Secondary	t1/2 ß of Rebamipide	Time taken for half the initial dose of Rebamipide administered to be eliminated from the body	From Period1/ Day1 to Period2/Day9
Secondary	Tmax of Rebamipide	Time at which the Cmax of Rebamipide is observed	From Period1/ Day1 to Period2/Day9
Secondary	AUCinf of Rebamipide	Area Under the plasma concentration versus time curve inifinite of Rebamipide	From Period1/ Day1 to Period2/Day9