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Plasma concentration determination and pharmacokinetics study of Nirmatrelvir/Ritonavir tablets in children

Plasma concentration determination and pharmacokinetics study of Nirmatrelvir/Ritonavir tablets in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071753
Enrollment
Unknown
Registered
2023-05-24
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Nirmatrelvir/Ritonavir group:None

Sponsors

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients taking Nirmatrelvir/Ritonavir tablets due to COVID-19 infection; 2. Age 0-18, gender unlimited; 3. The subjects and their guardians are willing to comply with the procedures and operations specified in the study protocol; 4. The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. The subject is known to be allergic to the ingredients contained in any study drug; 2. Subjects taking CYP3A inducers, inhibitors, and other drugs known to affect Nirmatrelvir or Ritonavir concentrations (e.g., carbamazepine, St. John's wort, clarithromycin, itraconazole, ketoconazole, voriconazole, posaconazole, verapamil, phenytoin, rifampicin, oxazepine, phenobarbital); 3. The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of Nirmatrelvir;Plasma concentrations of Ritonavir;

Countries

China

Contacts

Public ContactWu Juan

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

wujuan_0207@163.com+86 189 1839 7709

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026