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| Name | Class |
|---|---|
| Chonbuk National University Hospital | OTHER |
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This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Period 1: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state |
|
| Group B | Other | Period 1: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol HCI/Acetaminophen | Drug | Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state | Bio-equivalence of Cmax at steady state of tramadol and acetaminophen | 0 to 36 hour |
| Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state | Bio-equivalence of AUC at steady state of tramadol and acetaminophen | 0 to 36 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | Tmax of tramadol and acetaminophen at steady state. | 0 to 36 hour |
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25618318 | Derived | Im YJ, Jeon JY, Kim EY, Kim Y, Oh DJ, Yoo JS, Shin DH, Chae SW, Kim MG. An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects. Clin Ther. 2015 Feb 1;37(2):376-89. doi: 10.1016/j.clinthera.2014.12.007. Epub 2015 Jan 22. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C478659 | Ultracet |
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|
Half-life of tramadol and acetaminophen at steady state. |
| 0 to 36 hour |
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | Accumulation index of tramadol and acetaminophen at steady state. | 0 to 36 hour |
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | Cmax of O-desmethyltramadol at steady state | 0 to 36 hour |
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | AUC of O-desmethyltramadol at steady state | 0 to 36 hour |
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | Tmax of O-desmethyltramadol at steady state | 0 to 36 hour |
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | Half-life of O-desmethyltramadol at steady state | 0 to 36 hour |