Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers
Condition: Healthy
Intervention: Deferiprone sustained-release; Deferiprone immediate-release
Intervention description: Deferiprone sustained-release tablets; Deferiprone immediate-release tablets
Intervention MeSH terms: Deferiprone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Deferiprone; Deferiprone sustained-release tablets; Pharmacokinetics

Summary:

      The purpose of this study was to evaluate the pharmacokinetic and safety profile of the
      sustained-release formulation of deferiprone under both fasting and fed conditions, and
      evaluate the relative bioavailability of this sustained-release formulation when compared to
      immediate-release formulation of deferiprone under fasting conditions.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Meeting the age, body mass index (BMI) and weight requirements.

          -  Signing the Informed Consent Form.

          -  Acceptable alcohol and/or drug screen at check-in of each period.

          -  Acceptable health, blood pressure, pulse rate and temperature at check-in.

          -  Being a non-smoker.

          -  Female subjects of childbearing potential should be either sexually inactive
             (abstinent) for 60 days prior to the first dose of the study and throughout the study,
             and for 30 days after completion of the study, or be using an acceptable method of
             birth control.

        Exclusion Criteria:

          -  A history of presence of significant asthma, chronic bronchitis, seizure, diabetes,
             migraine, hypertension, cardiovascular, pulmonary, neurological conditions,
             psychiatric conditions, hepatic, renal, hematopoietic or gastrointestinal diseases or
             ongoing infectious diseases, or any other significant abnormality as evidenced by a
             medical history and physical examination.

          -  Blood chemistry, hematology, international normalized ratio, partial thromboplastin
             time and urinalysis values outside clinically acceptable limits.

          -  A positive screen for Hepatitis B surface antigens, Hepatitis C antibodies or HIV.

          -  Significant abnormality found on ECG.

          -  Known sensitivity to deferiprone or any components of the Ferriprox tablets.

          -  Requiring other medication at the time of the study. Oral, injectable or topical
             contraceptives, and contraceptive implants are permitted as they are acceptable
             methods of contraception.

          -  Acetaminophen use within 2 weeks prior to dosing and for the duration of the study.

          -  History of drug or alcohol abuse within the last 6 months.

          -  Any known enzyme inducing or inhibiting drug taken within 30 days before the study.

          -  History of long QT syndrome, cardiac arrhythmias.

          -  Infection within two weeks prior to dosing.

          -  Participation in an investigational drug study within 30 days prior to first dosing in
             this study.

          -  Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL
             of whole blood within 56 days prior to drug administration.

          -  Positive test for pregnancy at medical screening or prior to dosing in either period.

          -  Female subjects who are breast-feeding.

          -  Absolute neutrophil count (ANC) <= 1.0 x 10E9 cells/L prior to dosing for each period.