Healthy subjects
Conditions
Interventions
Product Name: Exjade
Pharmaceutical Form: Film-coated tablet
Trade Name: Exjade
Pharmaceutical Form: Dispersible tablet
Sponsors
Novartis Pharmaceuticals Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy male or female aged 18-55 years -Vital signs (after 3 minutes of rest as measured in the supine position) with the following ranges: oral body temperature 35-37.5°C, sysotlic blood preasure 90-140 mm Hg, diastolic blood preasure 60-90 mm Hg, pulse rate 40-90bpm - Wieght between 60-100kg and body mass index between 18kg/m² and 33kg/m² - Serum ferritin value of >=20ng/mL, total iron binding capacity of 250-370 ?g/dL and iron:TIBC ratio of >=15% at visit 1 - Laboratory values within normal ranges that were within 2 weekds priorto starting study treatment, unless deemed not clinically significant by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History or presence of hematological disorders that included but were not limited to: anemia, recurrent anemia, , iron deficiency, leukemia, lymphoma, etc. - History or presenc of ophtalmic symptoms and/or disorders that included but were not limited to: cataract, retinal changes, glaucoma, optic neuris, etc. with the exception of refractory disorders (e.g. myopia, astigmatism).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the PK comparability of deferasirox with a reduced dosage strenght of the Film-coated tablet(FCT) vs. the dispersible tablets (DT) in healthy subjects under fasted conditions.;Secondary Objective: Evaluate the safety an tolerability of deferasirox Film-coated tablet(FCT) in comparison to the dispersible tablets (DT) in healthy subjects under fasted conditions.;Primary end point(s): Primary PK parameters: Cmax, AUClast and AUCinf Secondary PK parameters: Tmax, T1/2 and Lambda_z;Timepoint(s) of evaluation of this end point: Pre-dose 0.5 h, 1.0 h, 1.5 h, 2.0 h, 3.0 h, 4.0 h, 6.0 h, 8.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, and 72.0 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the safety an tolerability of deferasirox Film-coated tablet(FCT) in comparison to the dispersible tablets (DT) in healthy subjects under fasted conditions. Safety assessments including AEs, vitals, ECGs laboratory parameters.;Timepoint(s) of evaluation of this end point: Since iron supplements are provided (form day -14 until -7) until 30 days after End of Treatment Visit | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed