Trials / Unknown
UnknownNCT04397913
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Shandong University · Academic / Other
- Sex
- All
- Age
- 28 Days
- Healthy volunteers
- Not accepted
Summary
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.
Detailed description
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paracetamol | 15 mg/kg, q6h |
| DRUG | Ibuprofen | 10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day |
Timeline
- Start date
- 2020-05-25
- Primary completion
- 2023-01-30
- Completion
- 2023-05-06
- First posted
- 2020-05-21
- Last updated
- 2020-05-21
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04397913. Inclusion in this directory is not an endorsement.