A study to compare two different forms of the same medicine (deferasirox tablet that is dissolved in liquid form vs. 2 doses of deferasirox granular form) to see how much of each type of medicine ends up in the blood.

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

Registration Number: EUCTR2016-000308-28-Outside-EU/EEA

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 97

Inclusion Criteria

Healthy subjects between 20 and 45 years of age; subjects weighing between
50 kg and 100 kg with a body mass index between 18.5 and 25 kg/m2; serum ferritin value = 20 ng/mL,
total iron binding capacity in the range of 250 to 450 µg/dL, and iron/TIBC ratio = 15% at Screening
Visit.
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 97
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; history or presence of
ophthalmic symptoms and/or disorders; history or presence of clinical manifestations of postural
hypotension; history or presence of any active medical conditions or clinically significant findings that
might alter the absorption, distribution, metabolism or excretion of deferasirox, as judged to be relevant
by the Investigator; any use of deferasirox.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours;Main Objective: The primary objective was to evaluate the PK comparability of two different doses of the deferasirox granule formulation in comparison to the reference dispersible formulation (Exjade®) in healthy Japanese subjects under fasted conditions.;Secondary Objective: The secondary objective was to evaluate the safety and tolerability of two different doses of the<br>deferasirox granule formulation in comparison to the reference dispersible formulation (Exjade®) in<br>healthy Japanese subjects under fasted conditions.;Primary end point(s): Primary PK parameters: AUClast, AUCinf, and Cmax<br>Secondary PK parameters: Tmax, T1/2, MRTlast and Lambda_z

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety assessments such as Adverse Events (AEs), vitals, ECGs and laboratory abnormalities ;Timepoint(s) of evaluation of this end point: 30 (up to 37) days after the End of Treatment Visit.