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| Name | Class |
|---|---|
| Chungnam National University Hospital | OTHER |
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The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DW-0919 | Active Comparator |
| |
| DW-0920 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DW-0920 | Drug | Dosage form: Extended release tablet Dosage: 2 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of DW-0919(Acetaminophen, Tramadol) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 | |
| Cmax of DW-0919(Acetaminophen, Tramadol) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 | |
| AUC of DW-0920(Acetaminophen, Tramadol) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 | |
| Cmax of DW-0920(Acetaminophen, Tramadol) | 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35800670 | Derived | Kim HC, Yoon DY, Lee S, Jang IJ, Hong JH, Kim J. Comparative pharmacokinetics between two tablets of tramadol 37.5 mg/acetaminophen 325 mg and one tablet of tramadol 75 mg/acetaminophen 650 mg for extended-release fixed-dose combination. Transl Clin Pharmacol. 2022 Jun;30(2):112-119. doi: 10.12793/tcp.2022.30.e12. Epub 2022 Jun 27. |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| DW-0919 | Drug | Dosage form: Extended release tablet Dosage: 1 tablet |
|
|
| Aniline Compounds |
| D000588 | Amines |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |