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

Bioequivalence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980458
• Other study ID #: 1221def09ct
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2016
• Last updated: December 6, 2016
• Start date: August 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: SocraTec R&D GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Deferiprone 500Mg Tablet

• Deferiprone 500 MG Oral Tablet [Ferriprox]

Locations

Country	Name	City	State
Germany	SocraTec R&D GmbH Clinical Pharmacology Unit	Erfurt	Thüringen

Sponsors (2)

Lead Sponsor	Collaborator
SocraTec R&D GmbH	SocraMetrics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone		8 hours interval	No
Primary	Peak Plasma Concentration (Cmax) for deferiprone		8 hours interval	No
Secondary	Number of participants with treatment-related adverse events		from fist dose until discharge of the subject (approx. 2 weeks)	Yes