A study to compare two different forms of the same medicine (deferasirox tablet that is dissolved in liquid form vs. deferasirox film-coated tablet form) to see how much of each type of medicine ends up in the blood.

• Conditions: Healthy subjects; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-000248-32-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-15
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 26

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

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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 Outcome Measures

Name	Time	Method
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.<br>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