Healthy volunteers, 70+ years of age (administration of an antipyretic, analgesic drug)
Conditions
Interventions
Trade Name: DAFALGAN 500 mg tabletten
Product Name: DAFALGAN 500 mg tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Other descriptive name: Acetaminophen
Co
Sponsors
KU Leuven - Drug Delivery and Disposition
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Male or female aged 70 years or older 3. No clinically significant abnormalities (as determined by the Principal Investigator) 4. Must be able to understand the requirements of the study and must be willing to comply with the requirements of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: 1. Participant has a history of acute/chronic gastrointestinal disease(s), hepatic cirrhosis, renal impairment 2. Any disorder, which in the Investigator’s opinion, might jeopardise the participant’s safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial 4. Any medication that influences gastric motility 5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device 6. HIV, HBV or HCV infection 7. Donated plasma in the 7 days or blood in the 3 months preceding study drug administration 8. Inability to communicate well with the Investigator and study staff (i.e., language problem, poor mental development or impaired cerebral function). 9. Inability to consume the tablets provided in the study 10. History of alcohol or drug abuse within the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of sparkling water instead of tap water on the early absorption of paracetamol in the elderly, as measured by the systemic AUC0-30 min after oral intake. ;Secondary Objective: To explore the effect of sparkling water instead of tap water on additional pharmacokinetic parameters of paracetamol in the elderly.;Primary end point(s): - AUC0-30 min (µg.h/mL);Timepoint(s) of evaluation of this end point: At pre dose, 5, 10, 15, 20, 25, 30 min post treatment administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -AUC0-inf (µg.h/mL) -AUC0-t (µg.h/mL) -Cmax (µg/mL) -tmax (min) ;Timepoint(s) of evaluation of this end point: At pre dose, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 180, 240, 300, 360 and 480 min post treatment administration | — |
Countries
Belgium
Contacts
Public ContactDrug Delivery and Disposition
KU Leuven
Outcome results
None listed