BioequivalencePhase 1NCT03018015
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
A Phase 1 study testing Ibuprofen 400 mg oral powder, Ibuprofen 400 mg film-coated tablet and Ibuprofen 400 mg soft capsule 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 assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Ibuprofen 400 mg oral powder, Ibuprofen 400 mg film-coated tablet and Ibuprofen 400 mg soft capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Oct 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sex: male/female
- ethnic origin: Caucasian
- age: 18 years or older
- body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m², body weight > 40 kg
- good state of health
- non-smoker or ex-smoker for at least 3 months
- 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 gastrointestinal bleeding or perforation, related to previous NSAID therapy
- existing, or history of, recurrent gastrointestinal ulcer/ bleeding
- conditions involving an increased tendency to bleeding
Show all 34Show fewer
- active or known inflammatory bowel diseases (e.g. colitis ulcerosa, Crohn´s disease)
- 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
- history of hypersensitivity reactions (e.g. bronchial spasm, asthma, rhinitis, urticaria, or angioedema) after intake of acetylsalicylic acid or other NSAIDs
- subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- existing, or history of, bronchial asthma, chronic rhinitis or allergic diseases unless it is judged as not relevant for the clinical trial by the investigator
- subjects with hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- systolic blood pressure < 90 or > 145 mmHg
- diastolic blood pressure < 60 or >90 mmHg
- heart rate < 50 bpm or > 90 bpm
- laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator except parameters ASAT, ALAT, bilirubin and creatinine (see exclusion criterion No. 18)
- laboratory values: ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20 % ULN and creatinine > 9 μmol/l ULN
- 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-HCVtest
- acute or chronic diseases which may interfere with the pharmacokinetics of the IMP
- history of or current drug or alcohol dependence
- positive alcohol or drug test at screening examination
- regular intake of alcoholic food or beverages of ≥ 40 g pure ethanol for male or ≥ 20 g pure ethanol for female 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 (except hormonal contraceptives)
- subjects, who report a frequent occurrence of migraine attacks
- positive pregnancy test at screening examination
- pregnant or lactating women
- female subjects who do not agree to apply highly effective contraceptive methods
- 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 Newly Developed Ibuprofen Oral Powder Formulation in Comparison With Two Marketed Reference Products in a Single Dose, 3-period-crossover Design Under Fasting Conditions; Controlled, Open-label, Randomised Study With Bioequivalence Assessment
The present study will be conducted in order to assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen.
In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate.
All 3 immediate release preparations contain 400 mg ibuprofen.
Read the detailed description
The clinical trial will be performed in a single centre, open-label, randomised (order of treatments), balanced, 3-period, 6-sequence, single dose change-over design with administration under fasting conditions separated by a washout period of at least 2 treatment-free days.
Blood sample collection will be performed over 16 h after administration. This time is considered adequate to characterise 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.
- Conditions
- Bioequivalence
- Being tested
- Ibuprofen 400 mg oral powder, Ibuprofen 400 mg film-coated tablet, Ibuprofen 400 mg soft capsule
- Keywords
- Bioequivalence, Healthy, Bioavailability, Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mg oral powderDrug
Ibuprofen 400 mg film-coated tabletDrug
Ibuprofen 400 mg soft capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 400 mg oral powder | Experimental | oral fasted administration of 1 sachet of Ibuprofen 400 mg oral powder (Hermes Arzneimittel GmbH, Germany), containing 400 mg ibuprofen Receives: Drug: Ibuprofen 400 mg oral powder |
| Brufen 400 mg film-coated tablets | Active comparator | oral fasted administration of Brufen 400 mg film-coated tablets (Abbott Scandinavia AB, Sweden), containing 400 mg ibuprofen Receives: Drug: Ibuprofen 400 mg film-coated tablet |
| Spalt forte 400 mg Weichkapseln | Active comparator | oral fasted administration of Spalt forte 400 mg Weichkapseln (Pfizer Consumer Healthcare GmbH, Germany), containing 400 mg ibuprofen Receives: Drug: Ibuprofen 400 mg soft capsule |
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 ibuprofen
Measured: 16 hours interval
Peak Plasma Concentration (Cmax) for ibuprofen
Measured: 16 hours interval
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: from first 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 posted11 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionOct 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
- 30 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
- NCT03018015
- Sponsor's protocol ID
- 1325ib16ct
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Relative Bioavailability of a Newly Developed Ibuprofen Oral Powder Formulation in Comparison With Two Marketed Reference Products in a Single Dose, 3-period-crossover Design Under Fasting Conditions; Controlled, Open-label, Randomised Study With Bioequivalence Assessment
- ClinicalTrials.gov ID
- NCT03018015
- Acronym / sponsor ID
- 1325ib16ct
- Conditions
- Bioequivalence
- Keywords
- Bioequivalence, Healthy, Bioavailability, Ibuprofen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SocraTec R&D GmbHUniversity, hospital or other
- Collaborators
- SocraMetrics GmbH
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jan 2017 (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 assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen.
In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate.
All 3 immediate release preparations contain 400 mg ibuprofen.
Detailed description
The clinical trial will be performed in a single centre, open-label, randomised (order of treatments), balanced, 3-period, 6-sequence, single dose change-over design with administration under fasting conditions separated by a washout period of at least 2 treatment-free days.
Blood sample collection will be performed over 16 h after administration. This time is considered adequate to characterise 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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 400 mg oral powder | Experimental | Drug: Ibuprofen 400 mg oral powderoral fasted administration of 1 sachet of Ibuprofen 400 mg oral powder (Hermes Arzneimittel GmbH, Germany), containing 400 mg ibuprofen |
| Brufen 400 mg film-coated tablets | Active comparator | Drug: Ibuprofen 400 mg film-coated tabletoral fasted administration of Brufen 400 mg film-coated tablets (Abbott Scandinavia AB, Sweden), containing 400 mg ibuprofen |
| Spalt forte 400 mg Weichkapseln | Active comparator | Drug: Ibuprofen 400 mg soft capsuleoral fasted administration of Spalt forte 400 mg Weichkapseln (Pfizer Consumer Healthcare GmbH, Germany), containing 400 mg ibuprofen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- sex: male/female
- ethnic origin: Caucasian
- age: 18 years or older
- body-mass index (BMI): ≥ 18.5 kg/m² and ≤ 30.0 kg/m², body weight > 40 kg
- good state of health
Key exclusion criteria (34 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 gastrointestinal bleeding or perforation, related to previous NSAID therapy
- existing, or history of, recurrent gastrointestinal ulcer/ bleeding
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 |
|---|---|---|
| Ibuprofen 400 mg oral powder | Drug | Ibuprofen 400 mg oral powder |
| Ibuprofen 400 mg film-coated tablet | Drug | Brufen 400 mg film-coated tablets |
| Ibuprofen 400 mg soft capsule | Drug | Spalt forte 400 mg Weichkapseln |
Primary outcome
Area under the plasma concentration versus time curve (AUC0-tlast) for ibuprofen
Time frame: 16 hours interval
Peak Plasma Concentration (Cmax) for ibuprofen
Time frame: 16 hours interval
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: from first 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 11 Jan 2017.
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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 Ibuprofen 400 mg oral powder, Ibuprofen 400 mg film-coated tablet and Ibuprofen 400 mg soft capsule 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 34 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 11 Jan 2017. 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 ibuprofen (time frame: 16 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 11 Jan 2017.