A Drug Interaction Study of Mosapride and Rebamipide

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rebamipide
* Drug: Mosapride citrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R - R+M<br>R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. | Drug: Rebamipide<br>* oral administration, 3 times/day<br>* Other names: Mucosta® Tab.;Drug: Mosapride citrate<br>* oral administration, 3 times/day<br>* Other names: Gasmotin® tab.;|
| Experimental: R+M - R<br>R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. | Drug: Rebamipide<br>* oral administration, 3 times/day<br>* Other names: Mucosta® Tab.;Drug: Mosapride citrate<br>* oral administration, 3 times/day<br>* Other names: Gasmotin® tab.;|
| Experimental: M - R+M<br>R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. | Drug: Rebamipide<br>* oral administration, 3 times/day<br>* Other names: Mucosta® Tab.;Drug: Mosapride citrate<br>* oral administration, 3 times/day<br>* Other names: Gasmotin® tab.;|
| Experimental: R+M - M<br>R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. | Drug: Rebamipide<br>* oral administration, 3 times/day<br>* Other names: Mucosta® Tab.;Drug: Mosapride citrate<br>* oral administration, 3 times/day<br>* Other names: Gasmotin® tab.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mosapride citrate, Rebamipide, pharmacokinetic drug drug interaction, oral administration, healthy male subjects