NCT07372560

Pharmacometric Modeling of a Hospital Preparation

Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg/mL in Hypertensive Patients in Pediatric Hematology-oncology

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

Summary

Pediatric prescribers are very often faced with a lack of suitable therapies, particularly oral ones. This represents a major public health problem and necessitates adjustments to dosage or pharmaceutical form using medications marketed for adults, some of which contain excipients that may be harmful to children. This creates risks of dilution errors, administration errors, and the occurrence of adverse effects. Hospital pharmacy technicians are called upon daily to provide appropriate treatment for children. However, although this activity is authorized (Public Health Code, Good Preparation Practices), pharmacokinetic/pharmacodynamic studies on these preparations are only exceptionally carried out. Indeed, only stability studies are required to determine the expiration date of the preparation. Thus, prescribers are left without the necessary information to choose the dosage and administration schedule. Pediatric dosages are extrapolated from those for adults without any certainty of the treatment's effectiveness.

Detailed description

The pediatric hematology-oncology department wanted to include an oral form of nicardipine in its therapeutic arsenal. Nicardipine is a widely used antihypertensive drug for secondary hypertension, particularly that caused by corticosteroid use. This oral form is preferred for its flexibility in dosing, which is based on weight and blood pressure readings. A first formulation was developed in 2017 and subsequently optimized in terms of excipients and raw material availability, leading to a second formulation in 2021. Nicardipine oral solution has been routinely prepared, dispensed, and administered for many years. The lack of bibliographic data concerning the use of nicardipine in a pediatric population prevents us from understanding the pharmacokinetic (PK) parameters, which are nevertheless essential for optimizing the benefit/risk balance of the drug and for individualizing doses. This study aims to optimize the use of this preparation in the management of hypertension in pediatrics and to promote the benefits of this formulation. This study is valuable because it is situated within the context of the routine therapeutic management of a patient in the pediatric hematology-oncology department suffering from hypertension. It therefore does not entail any modification of the child's care.

Conditions

• Hypertensive Patients

Interventions

Type	Name	Description
OTHER	Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride	These pharmacokinetic parameters aim to optimize the use of this preparation in the management of pediatric hypertension. The pharmacokinetic parameters are: the area under the curve (AUC), the apparent volume of distribution (Vd/F), the apparent clearance (Cl/F), the maximum concentration (Cmax), the time to reach this concentration (Tmax), the elimination constant (ke), the elimination half-life (t1/2), the apparent intercompartmental clearance (Q/F), the apparent central volume (Vc/F), and the apparent peripheral volume (Vp/F). This kinetic profile will be obtained using Monolix® software modeling with the results of validated blood sampling methods. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: France