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Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA

NCT04397913 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2020-05-21

No results posted yet for this study

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.

Conditions

  • Patent Ductus Arteriosus

Interventions

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

Sponsors & Collaborators

  • West China Second University Hospital

    collaborator OTHER

  • Shandong University

    lead OTHER

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2023-01-30
Completion
2023-05-06
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04397913 on ClinicalTrials.gov