Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration

Study Overview
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Brief Summary
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The present study will be conducted in order to compare the bioavailability of the generic Test product (Deferiprone 500 Lipomed tablets, Lipomed AG, Switzerland) with a marketed Reference product (Ferriprox® film-coated tablets, Apotex Europe B.V., Germany) both containing 500 mg deferiprone. For this issue the pharmacokinetics will be characterised after single dose administration of each one tablet.

Detailed Description
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The study will be performed in an open-label, randomised (order of treatments), single dose, 2 period cross-over design with a wash out phase of at least three treatment free days between both administrations. Sample collection will be performed over eight hours after fasted administration. This time is considered adequate for the determination of plasma concentration vs. time profiles long enough for reliable estimation of the extent of absorption, i.e. the AUC derived from measurements is expected to cover at least 80% of the AUC extrapolated to infinity for deferiprone

Official Title
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Characterisation of Relative Bioavailability of a Generic Deferiprone Formulation in Comparison With a Marketed Reference Product in a Single Dose, 2-period-crossover Design Under Fasting Conditions; Controlled, Open, Randomised, no Blinded Study With Bioequivalence Assessment

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Deferiprone 500Mg Tablet
* Drug: Deferiprone 500 MG Oral Tablet [Ferriprox]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sex: male ethnic origin: Caucasian age: 18 years or older body-mass index (BMI): >=18.5 kg/m² and <= 30.0 kg/m² good state of health non-smoker or ex-smoker for at least 1 month written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial Exclusion Criteria: existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator heart rate < 50 bpm laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator laboratory values: CRP > 5 mg/L, ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20 % ULN and creatinine > 0.1 mg/dL positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test (if positive to be verified by test for HBc-IgM) or anti-HCV-test history of recurrent episodes of neutropenia or history of agranulocytosis acute or chronic diseases which may interfere with the pharmacokinetics of the IMP history of or current drug or alcohol dependence regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day subjects who are on a diet which could affect the pharmacokinetics of the active ingredient regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day blood donation or other blood loss of more than 400 ml within the last 2 months prior to individual enrolment of the subject administration of any investigational medicinal product during the last 2 months prior to individual enrolment of the subject regular treatment with any systemically available medication treatment with medicinal products which might cause neutropenia or agranulocytosis subjects, who report a frequent occurrence of migraine attacks subjects suspected or known not to follow instructions subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deferiprone 500 Lipomed film-coated tablets<br>Oral fasted administration of one film-coated tablet of Deferiprone 500 Lipomed film-coated tablets (Lipomed AG, Switzerland), containing 500 mg deferiprone | Drug: Deferiprone 500Mg Tablet<br> <br> |
| Active Comparator: Ferriprox® film-coated tablets<br>Oral fasted administration of one film-coated tablet of Ferriprox® film-coated tablets (Apotex Europe B.V., Germany), containing 500 mg deferiprone | Drug: Deferiprone 500 MG Oral Tablet [Ferriprox]<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone |  | 8 hours interval | 
| Peak Plasma Concentration (Cmax) for deferiprone |  | 8 hours interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | from fist dose until discharge of the subject (approx. 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Bioequivalence, Deferiprone