Overview
Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration
Status:
Completed
Completed
Trial end date:
2016-09-01
2016-09-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
SocraTec R&D GmbHCollaborator:
SocraMetrics GmbHTreatments:
Deferiprone
Criteria
Inclusion Criteria:1. sex: male
2. ethnic origin: Caucasian
3. age: 18 years or older
4. body-mass index (BMI): >=18.5 kg/m² and <= 30.0 kg/m²
5. good state of health
6. non-smoker or ex-smoker for at least 1 month
7. 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:
1. existing cardiac and/or haematological diseases or pathological findings, which might
interfere with the safety or tolerability of the active ingredient
2. existing hepatic and/or renal diseases or pathological findings, which might interfere
with the safety or tolerability, and/or pharmacokinetics of the active ingredient
3. existing gastrointestinal diseases or pathological findings, which might interfere
with the safety, tolerability, absorption and/or pharmacokinetics of the active
ingredient
4. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS
and/or psychiatric disorders
5. known allergic reactions to the active ingredients used or to constituents of the
pharmaceutical preparations
6. subjects with severe allergies or multiple drug allergies unless it is judged as not
relevant for the clinical trial by the investigator
7. heart rate < 50 bpm
8. laboratory values out of normal range unless the deviation from normal is judged as
not relevant for the clinical trial by the investigator
9. laboratory values: CRP > 5 mg/L, ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20 %
ULN and creatinine > 0.1 mg/dL
10. 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
11. history of recurrent episodes of neutropenia or history of agranulocytosis
12. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
13. history of or current drug or alcohol dependence
14. regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male per day
15. subjects who are on a diet which could affect the pharmacokinetics of the active
ingredient
16. regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day
17. blood donation or other blood loss of more than 400 ml within the last 2 months prior
to individual enrolment of the subject
18. administration of any investigational medicinal product during the last 2 months prior
to individual enrolment of the subject
19. regular treatment with any systemically available medication
20. treatment with medicinal products which might cause neutropenia or agranulocytosis
21. subjects, who report a frequent occurrence of migraine attacks
22. subjects suspected or known not to follow instructions
23. 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