Allergic Rhinoconjunctivitis and chronic urticaria MedDRA version: 12.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis MedDRA version: 12.0 Level: LLT Classification code 10009159 Term: Chronic urticaria
Conditions
Interventions
Product Name: Bilastine
Product Code: F-96221-BM1
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Bilastine
CAS Number: 202189-78-4
Current Sponsor code: F-96221-BM1 (polymorph I)
Concent
Sponsors
FAES FARMA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Either sex aged from = 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Female subjects of childbearing potential. If menarche occurs after study enrolment and during the dosing period, the subject should be discontinued from the treatment and followed up for safety as per protocol. Occurrence of menarche in the course of the study should always be documented. 2.Intake of another investigational medication in another clinical study within 30 days prior to the first study drug intake. 3.Clinically significant ECG abnormalities as judged by the investigator (e.g., Wolff-Parkinson-White [WPW] syndrome, long QT syndrome). 4.Known allergy/hypersensitivity to the study drug or its inactive ingredients. 5.Any clinical conditions or circumstances that in the opinion of the investigator would make the subject unsuitable for the study (e.g., hepatic impairment, renal impairment, mental impairment, cardiac disease). 6.Subjects with known positive Hepatitis B surface antigen (Hbs Ag), or Hepatitis C antibody or who are known to be human immunodeficiency virus (HIV) positive. No testing will be required for this study. 7.Subjects who are expected to take during the study period or have taken any of the following medications prior to inclusion in the study and have not complied with the specified wash out period of 7 days unless otherwise noted: o Oral corticosteroids. o Oral antihistamines: loratadine, desloratadine, and fexofenadine. o Anti-leukotrienes o Amoxicillin, benzylpenicillin, macrolide antibiotics, imidazolic antifungals (systemic) o Omeprazol o Aspirin, ibuprofen o Carbamazepine o St. John’s Wort (15 days) 8.Hypersensitivity to H1 antihistamines or benzimidazoles. 9.Ingestion of citrus fruits and cranberries or any fruit juice or any other well known PgP or organic anion transporter polypeptide (OATP) inhibitor, inducer, or substrate within 7 days prior to first dose of study medication. 10.Mentally disabled minors or Minors who by official order have been institutionalised (e.g., in orphanages) must be excluded from participation. 11.Minors who explicitly refuse to take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the pharmacokinetics of bilastine in children (aged 2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis and/or perennial allergic rhinitis [SAR/PAR]) or chronic urticaria (CU) in order to ascertain whether the proposed dose (10 mg/day or lower) matches the systemic exposure seen in adults with the 20 mg/day dose. ;Secondary Objective: The secondary objectives are to describe the safety and tolerability of a repeated administration of bilastine in the aforementioned paediatric subset with allergic rhinoconjunctivitis (SAR/PAR) or chronic urticaria (CU).;Primary end point(s): Determination of plasma concentrations versus time (between 1 and 6 samples per subject at various time intervals after dosing according to an optimised sampling protocol) in order to perform a population pharmacokinetic analysis. Bilastine plasma concentrations will be measured using a liquid chromatography/mass mass spectrometry (LC/MS/MS) micro method. | — |
Countries
Germany, Spain, Sweden
Outcome results
None listed