A Drug Interaction Study of Mosapride and Rebamipide

NCT ID: NCT02106130

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-08-31

Brief Summary

The investigators investigate the potential pharmacokinetic drug-drug interaction between Mosapride citrate 5 mg and Rebamipide 100 mg in healthy male volunteers who receive Mosapride citrate 5 mg, Rebamipide 100 mg, and both together in a 2 period repeatedly.

Detailed Description

To evaluate the safety, drug-tolerance, pharmacokinetics of Mosapride citrate 5 mg or Rebamipide 100 mg monotherapy or Mosapride citrate 5 mg and Rebamipide 100 mg combination in healthy male subjects.

Conditions

Healthy

Study Design

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

Study Groups

R - R+M

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Group Type: EXPERIMENTAL

Rebamipide

Intervention Type: DRUG

oral administration, 3 times/day

Mosapride citrate

Intervention Type: DRUG

oral administration, 3 times/day

R+M - R

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Group Type: EXPERIMENTAL

Rebamipide

Intervention Type: DRUG

oral administration, 3 times/day

Mosapride citrate

Intervention Type: DRUG

oral administration, 3 times/day

M - R+M

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Group Type: EXPERIMENTAL

Rebamipide

Intervention Type: DRUG

oral administration, 3 times/day

Mosapride citrate

Intervention Type: DRUG

oral administration, 3 times/day

R+M - M

R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.

Group Type: EXPERIMENTAL

Rebamipide

Intervention Type: DRUG

oral administration, 3 times/day

Mosapride citrate

Intervention Type: DRUG

oral administration, 3 times/day

Interventions

Rebamipide

oral administration, 3 times/day

Intervention Type: DRUG

Mosapride citrate

oral administration, 3 times/day

Intervention Type: DRUG

Other Intervention Names

Mucosta® Tab.; Gasmotin® tab.

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers, age 20 to 45 years

2. Body weight ≥ 55kg (male), ≥ 50kg (female)

3. Body weight index (BMI) 18.5 ~ 25

4. Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening

5. Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.

Exclusion Criteria

1. Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic·oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).

2. Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.

3. Subject has hypersensitivity reaction to drug (aspirin, antibiotics, including study durgs, etc.) or history of clinically significant hypersensitivity reaction.

4. Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg(Sitting blood pressure) during the screening procedure

5. Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test.

6. For women, pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test

7. Subject takes caffeine-containing food 5 cups per day

8. Subject continually drinks (in excess of 210g/week)

9. Subject smokes 10 cigarettes or more in one day

10. Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug within 1 week prior to the first medication (however, the subject can be included if other criteria are met according to the discretion of the investigator).

11. A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 30 days prior to the first dosing

12. Subject participated in another study and received medication within 2 months prior to the first medication day.

13. Subject received whole blood transfusion (500 mL) within 2 months prior to the first medication or blood transfusion within 1 month prior to the first medication.

14. Subject was judged not to be eligible according to the discretion of the investigator for other reasons.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-ok Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Severance Hospital

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ID_MotiReb_1201

Identifier Type: -

Identifier Source: org_study_id