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| Name | Class |
|---|---|
| SocraMetrics GmbH | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferiprone 500 Lipomed film-coated tablets | Experimental | Oral fasted administration of one film-coated tablet of Deferiprone 500 Lipomed film-coated tablets (Lipomed AG, Switzerland), containing 500 mg deferiprone |
|
| Ferriprox® film-coated tablets | Active Comparator | Oral fasted administration of one film-coated tablet of Ferriprox® film-coated tablets (Apotex Europe B.V., Germany), containing 500 mg deferiprone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferiprone 500Mg Tablet | Drug |
| ||
| Deferiprone 500 MG Oral Tablet [Ferriprox] |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | from fist dose until discharge of the subject (approx. 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelius Koch, MD | SocraTec R&D GmbH, Clinical Pharmacology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SocraTec R&D GmbH Clinical Pharmacology Unit | Erfurt | Thuringia | 99084 | Germany |
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| Drug |
|
| ID | Term |
|---|---|
| D000077543 | Deferiprone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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