Pharmacometric Modeling of a Hospital Preparation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-15
SponsorUniversity Hospital, Rouen

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged 1 to 15 years, male or female.

Patients followed in pediatric hematology-oncology.

Patients with a central venous catheter as part of their initial care and available for blood sampling.

Patients with a prescription for oral nicardipine (oral solution) whose formulation and/or dosage is/are not compatible with the commercial form of Loxen® 20 mg, requiring preparation.

Disqualifiers

Patient n'ayant pas un schéma d'administration toutes les 8 heures.

Hypersensibilité à la substance active.

Antécédent d'allergie à l'un des excipients (polysorbate 80, hypromellose, saccharine sodique, sorbate de potassium, acide citrique, citrate de sodium, saccharose).

Refus de participation de l'enfant, des parents ou du représentant légal.

Trial design

Treatments tested in this trial

  • Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride

Treatment groups

No treatment groups listed

Sponsors and collaborators