Trials / Not Yet Recruiting
Not Yet RecruitingNCT06135389
Population Pharmacokinetics of Paracetamol in Overweight and Obese Children
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the study is to define population pharmacokinetic parameters and variability factors for paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex.
Detailed description
This study will determine the pharmacokinetic parameters of paracetamol and its metabolites in overweight and obese children compared to children with normal weight for age and sex. The results will enable establishing dosage recommendations for paracetamol in overweight and/or obese children and adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Titration of paracetamol and its metabolites - scheme1 | 15 to 20 minutes and 1 to 2 hours after first perfusion and before second perfusion/administration of paracetamol |
| BIOLOGICAL | Titration of paracetamol and its metabolites - scheme 2 | 30 to 40' after first perfusion and before second perfusion/administration of paracetamol (residual concentration) |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2023-11-18
- Last updated
- 2025-01-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06135389. Inclusion in this directory is not an endorsement.