Status and phase
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Treatments
About
The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects.
Sex
Ages
Volunteers
Inclusion criteria
Age 18-65 years inclusive at the time of consent.
Must be considered "healthy".
Serum ferritin, hemoglobin and erythrocyte indices (packed cell volume, mean corpuscular volume and mean corpuscular hemoglobin concentration) within normal range.
Willingness to comply with any applicable contraceptive requirements of the protocol and is:
Body weight equal to or greater than 60kg.
Ability to swallow a dose of the investigational product.
Exclusion criteria
Subject has a clinically significant history or a disorder detected during the medical interview/physical examination.
Acute illness.
Oral condition:
Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment.
History of alcohol or other substance abuse within the year.
A positive screen for alcohol or drugs of abuse.
Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or<49mmHg.
Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody.
Current use of any other medication (including over-the-counter, herbal, or homeopathic preparations)
Current use of iron supplements and/or multivitamins.
Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products.
Donation of blood or blood products (e.g., plasma or platelets) within 60 days.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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