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

December 6, 2016 updated by: SocraTec R&D GmbH

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thüringen
      • Erfurt, Thüringen, Germany, 99084
        • SocraTec R&D GmbH Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deferiprone 500 Lipomed film-coated tablets
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
Active Comparator: Ferriprox® film-coated tablets
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]

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone
Time Frame: 8 hours interval
8 hours interval
Peak Plasma Concentration (Cmax) for deferiprone
Time Frame: 8 hours interval
8 hours interval

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with treatment-related adverse events
Time Frame: from fist dose until discharge of the subject (approx. 2 weeks)
from fist dose until discharge of the subject (approx. 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SocraTec R&D GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
SocraMetrics GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1221def09ct

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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