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| Name | Class |
|---|---|
| National Institute of Food and Drug Safety Evaluation, Korea | UNKNOWN |
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A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol | Experimental |
Isoproterenol Sensitivity Test
Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the plasma concentration-time curve) of carvedilol | predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose | |
| Cmax (Maximum plasma concentration) of carvedilol | predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Yong Chung, MD, PhD | Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Gyounggi | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29962926 | Derived | Jung E, Ryu S, Park Z, Lee JG, Yi JY, Seo DW, Lee J, Jeong HS, Kim JM, Oh WY. Influence of CYP2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamic Characteristics of Carvedilol in Healthy Korean Volunteers. J Korean Med Sci. 2018 May 23;33(27):e182. doi: 10.3346/jkms.2018.33.e182. eCollection 2018 Jul 2. |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Isoproterenol Sensitivity Test | Other | Day 0, 1, 8 : Isoproterenol Sensitivity Test |
|
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |