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| Name | Class |
|---|---|
| National Institute of Food and Drug Safety Evaluation (Republic of Korea) | UNKNOWN |
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This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of mycophenolate mofetil in pediatric hematopoietic stem cell transplantation patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | Administer 15-20mg/kg of mycophenolate mofetil twice daily. Blood sampling for pharmacokinetics(PK) of mycophenolate mofetil will be performed in all patients who have taken the investigational drug for at least 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter of melphalan | Analysis: Maximum plasma drug concentration (Cmax) | pre dose, post 1 hour, post 2 hour, post 6 hour |
| Pharmacokinetics parameter of melphalan | Analysis: Time to reach maximum plasma concentration (tmax) | pre dose, post 1 hour, post 2 hour, post 6 hour |
| Pharmacokinetics parameter of melphalan | Analysis: Area under the plasma concentration-time curve (AUC) | pre dose, post 1 hour, post 2 hour, post 6 hour |
| Pharmacokinetics parameter of melphalan | Analysis: Apparent total clearance of the drug from plasma after oral administration (CL/F) | pre dose, post 1 hour, post 2 hour, post 6 hour |
| Pharmacokinetics parameter of melphalan | Analysis: Apparent volume of distribution after non-intravenous administration (V/F) | pre dose, post 1 hour, post 2 hour, post 6 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyoung Jin Kang, MD, PhD | Contact | +82-2-2072-3304 | kanghj@snu.ac.kr | |
| Kyung Taek Hong, MD | Contact | +82-2-2072-3631 | hongkt@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hyoung Jin Kang, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |