Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

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:

1. The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
2. The association between the PK parameters and pathophysiological factors
3. The correlation between PK parameters and clinical parameters.

Inclusion Criteria:

• a minimum age of 80 years
• admission to the acute geriatrics ward
• oral intake of paracetamol 1000 milligram (mg) in tablet form tid
• a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling)

Exclusion Criteria:

• palliative care setting with downgrading of care