A Drug Interaction Study of Mosapride and Rebamipide

Sponsor

IlDong Pharmaceutical Co Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT02106130

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Rebamipide Drug: Mosapride citrate	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Multiple Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Mosapride Citrate and Rebamipide After Oral Administration in Healthy Volunteers

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R - R+M R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.	Drug: Rebamipide oral administration, 3 times/day Other Names: Mucosta® Tab. Drug: Mosapride citrate oral administration, 3 times/day Other Names: Gasmotin® tab.
Experimental: R+M - R R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.	Drug: Rebamipide oral administration, 3 times/day Other Names: Mucosta® Tab. Drug: Mosapride citrate oral administration, 3 times/day Other Names: Gasmotin® tab.
Experimental: M - R+M R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.	Drug: Rebamipide oral administration, 3 times/day Other Names: Mucosta® Tab. Drug: Mosapride citrate oral administration, 3 times/day Other Names: Gasmotin® tab.
Experimental: R+M - M R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally.	Drug: Rebamipide oral administration, 3 times/day Other Names: Mucosta® Tab. Drug: Mosapride citrate oral administration, 3 times/day Other Names: Gasmotin® tab.

Outcome Measures

Primary Outcome Measures

AUCτ,ss of Mosapirde citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
Cmax,ss of Mosapirde citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
AUCτ,ss of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
Cmax,ss of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]

Secondary Outcome Measures

AUClast,ss of Mosapride citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
AUCinf,ss of Mosapride citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
Tmax,ss of Mosapride citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
t1/2 of Mosapride citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
Cmin,ss of Mosapride citrate 5mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
AUClast,ss of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
AUCinf,ss of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
Tmax,ss of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
t1/2 of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]
Cmin,ss of Rebamipide 100mg [D-1 D2, D7, D9: pre-dose / D3~4, D10~11: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 25 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers, age 20 to 45 years
Body weight ≥ 55kg (male), ≥ 50kg (female)
Body weight index (BMI) 18.5 ~ 25
Acceptable serum test, hematologic test, blood chemistry examination, urin test and ECG, physical examination during screening
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:

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).
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.
Subject has hypersensitivity reaction to drug (aspirin, antibiotics, including study durgs, etc.) or history of clinically significant hypersensitivity reaction.
Systolic blood pressure > 150mmHg or <90mmHg, Diastolic blood pressure >100mmHg or <50mmHg(Sitting blood pressure) during the screening procedure
Subject has history of drug abuse or tested positive to abused drug in the urine drug screening test.
For women, pregnant or breastfeeding woman or woman who was confirmed to be pregnant in the pregnancy test
Subject takes caffeine-containing food 5 cups per day
Subject continually drinks (in excess of 210g/week)
Subject smokes 10 cigarettes or more in one day
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).
A subject who takes grapefruit, grapefruit juice, or grapefruit-containing products within 30 days prior to the first dosing
Subject participated in another study and received medication within 2 months prior to the first medication day.
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.
Subject was judged not to be eligible according to the discretion of the investigator for other reasons.