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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R - R+M | Experimental | R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. |
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| R+M - R | Experimental | R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. |
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| M - R+M | Experimental | R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. |
|
| R+M - M | Experimental | R : Rebamipide 100mg, M : Mosapride citrate 5mg, All drugs will be administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide | Drug | oral administration, 3 times/day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-ok Kim, MD | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
| C062720 | mosapride |
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| Mosapride citrate | Drug | oral administration, 3 times/day |
|
|
| 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 |