BioequivalencePhase 1NCT02980458
Characterisation of Relative Bioavailability With Bioequivalence Assessment of Deferiprone Tablets After Oral Single Dose Administration
A Phase 1 study testing Deferiprone 500Mg Tablet and Deferiprone 500 MG Oral Tablet [Ferriprox] in people with Bioequivalence, run by SocraTec R&D GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Deferiprone 500Mg Tablet and Deferiprone 500 MG Oral Tablet [Ferriprox]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2016to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
SocraTec R&D GmbH Clinical Pharmacology Unit
Erfurt, Thuringia, 99084
About this study
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
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.
Read the 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
- Conditions
- Bioequivalence
- Being tested
- Deferiprone 500Mg Tablet, Deferiprone 500 MG Oral Tablet [Ferriprox]
- Keywords
- Healthy, Bioequivalence, Deferiprone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferiprone 500Mg TabletDrug
Deferiprone 500 MG Oral Tablet [Ferriprox]Drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Deferiprone 500Mg Tablet |
| 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 Receives: Drug: Deferiprone 500 MG Oral Tablet [Ferriprox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone
Measured: 8 hours interval
Peak Plasma Concentration (Cmax) for deferiprone
Measured: 8 hours interval
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: from fist dose until discharge of the subject (approx. 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- SocraTec R&D GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- SocraMetrics GmbH
- Responsible party
- Sponsor
- Investigators
- Cornelius Koch, MD, Principal investigator, SocraTec R&D GmbH, Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980458
- Sponsor's protocol ID
- 1221def09ct
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02980458
- Acronym / sponsor ID
- 1221def09ct
- Conditions
- Bioequivalence
- Keywords
- Healthy, Bioequivalence, Deferiprone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SocraTec R&D GmbHUniversity, hospital or other
- Collaborators
- SocraMetrics GmbH
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferiprone 500 Lipomed film-coated tablets | Experimental | Drug: Deferiprone 500Mg TabletOral 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 | Drug: Deferiprone 500 MG Oral Tablet [Ferriprox]Oral fasted administration of one film-coated tablet of Ferriprox® film-coated tablets (Apotex Europe B.V., Germany), containing 500 mg deferiprone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferiprone 500Mg Tablet | Drug | Deferiprone 500 Lipomed film-coated tablets |
| Deferiprone 500 MG Oral Tablet [Ferriprox] | Drug | Ferriprox® film-coated tablets |
Primary outcome
Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone
Time frame: 8 hours interval
Peak Plasma Concentration (Cmax) for deferiprone
Time frame: 8 hours interval
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: from fist dose until discharge of the subject (approx. 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelius Koch, MD principal investigator
SocraTec R&D GmbH, Clinical Pharmacology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deferiprone 500Mg Tablet and Deferiprone 500 MG Oral Tablet [Ferriprox] in people with Bioequivalence, run by SocraTec R&D GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC0-tlast) for deferiprone (time frame: 8 hours interval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.