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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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The goal of this exploratory study is the characterization of the pharmacokinetic (PK) profile of paracetamol in older patients and the specific PK (pharmacokinetic) variables associated with plasma exposure in this population.
The goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific PK variables associated with plasma exposure in this population. The primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (AUC), peak plasma concentration after administration of paracetamol (Cmax) and the time at which the Cmax is observed (Tmax) of paracetamol. The secondary endpoint consists of 3 sub-endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol oral tablets 1g tid | Experimental | Patients received paracetamol one gram three times daily. Venopuncture for PK profiling |
|
| Paracetamol oral granules 1g tid | Experimental | Patients received paracetamol one gram three times daily. Venopuncture for PK profiling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venopuncture for PK profiling | Procedure | Blood samples at T0, T0.5, T1, T2, T4, T6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the pharmacokinetic parameters: AUC | Area under the curve (AUC) | 8 hours (= during 1 dosing interval at steady state) |
| Identification of the pharmacokinetic parameters: Cmax | Peak plasma concentration after administration of paracetamol (Cmax) | 8 hours (= during 1 dosing interval at steady state) |
| Identification of the pharmacokinetic parameters: Tmax | The time at which the Cmax is observed (Tmax) of paracetamol | 8 hours (= during 1 dosing interval at steady state) |
| Measure | Description | Time Frame |
|---|---|---|
| Variability in plasma exposure: Vd | Volume of distribution (Vd) | 8 hours (= during 1 dosing interval at steady state) |
| Variability in plasma exposure: t1/2 | Elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Spriet, PharmD PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
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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 |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 8 hours (= during 1 dosing interval at steady state) |
| Variability in plasma exposure: Cl | Clearance (Cl) | 8 hours (= during 1 dosing interval at steady state) |
| The association between the AUC (area under the curve) of paracetamol and patient related factors. | Multivariate analysis will be performed with AUC (area under the curve) as outcome. This will allow to identify variables influencing AUC of paracetamol. Patient related factors include amongst others age, weight, albumin, bilirubin, serum creatinin and co medication. | 8 hours (= during 1 dosing interval at steady state) |
| The association between the AUC (area under the curve) of paracetamol and pain scores. | Pain scores will be based on the Numeric Rating Scale with a score of 0 indicating no pain and a score of 10 indicating worst imaginable pain. | 8 hours (= during 1 dosing interval at steady state) |
| Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum | Correlation between two different assays will be determined through Bland Altman statistics. | 8 hours (= during 1 dosing interval at steady state) |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |