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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.

A randomized, open label, six sequences, cross-over study in healthy Japanese subjects to evaluate the pharmacokinetic comparability of deferasirox granule formulation with the reference dispersible tablet formulation (Exjade)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-000308-28-Outside-EU/EEA
Enrollment
97
Registered
2016-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult subjects

Interventions

Product Name: Exjade Pharmaceutical Form: Granules Trade Name: Exjade Pharmaceutical Form: Dispersible tablet

Sponsors

Novartis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 deferasirox granule formulation in comparison to the reference dispersible formulation (Exjade®) in healthy Japanese subjects under fasted conditions.;Primary end point(s): Primary PK parameters: AUClast, AUCinf, and Cmax Secondary PK parameters: Tmax, T1/2, MRTlast and Lambda_z—

Secondary

MeasureTime frame
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.—

Countries

Japan

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026