Status:
COMPLETED
S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet
Lead Sponsor:
SocraTec R&D GmbH
Collaborating Sponsors:
Teikoku Seiyaku Co., Ltd.
SocraMetrics GmbH
Conditions:
Comparative Bioavailability
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
Teikoku Seiyaku Co., Ltd. (Japan) is developing a new Esflurbiprofen Hydrogel Patch (EFHP), a transdermal product containing 165 mg of the S-enantiomer of flurbiprofen (S-flurbiprofen) as its active p...
Detailed Description
This single centre, open-label, randomised (order of treatments), balanced, multiple dose trial will be performed in a 2-period, 2-sequence-crossover design. The Test Product (patch) will be applied ...
Eligibility Criteria
Inclusion
- age: 18 to 64 years (inclusive)
- 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 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
Exclusion
- Safety concerns
- existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- existing or history of hypertension and/or heart failure
- 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
- active, or history of, ulcerative colitis, Crohn's disease, peptic ulceration or gastrointestinal haemorrhage
- existing metabolic, endocrine and/or immunologic diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient
- diabetes mellitus
- hyperlipidaemia (LDL \> 160 mg/dL; HDL \< 35 mg/dL; triglycerides \> 200 mg/dL; cholesterol \> 240 mg/dL)
- history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- presence or history of acute or chronic diseases of the skin (e.g. atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma), any dermatological condition or skin sensitivity which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient
- existing or history of bronchial asthma
- known allergic reactions (e.g. bronchospasm, rhinitis, angioedema, or urticaria) to the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to constituents of the pharmaceutical preparations
- history of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator
- fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- galactose intolerance or Lapp lactase deficiency
- systolic blood pressure \< 90 or \> 139 mmHg
- diastolic blood pressure \< 60 or \> 89 mmHg
- heart rate \< 50 bpm or \> 90 bpm
- QTc interval \> 450 ms for men and \> 470 ms for women
- laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator
- ASAT \> 20% ULN, ALAT \> 10% ULN, bilirubin \> 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine \> 0.1 mg/dL ULN (limit of \> 0.1 mg/dL correspondents to of \> 9 µmol/l ULN).
- positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or anti-HCV-test
- symptoms of, or diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the subject
- contact to persons in risk regions as defined by the Robert Koch Institute within the last 14 days prior to individual enrolment of the subject
- direct contact to persons with symptoms of, or diagnosis of COVID-19 within the last 14 days prior to individual enrolment of the subject Lack of suitability for the clinical trial
- skin abnormality (e.g. tattoo (including tattoo that was removed), scar, sunburn or obvious difference in skin colour), open sores, or excessive hair at the application site
- 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 \>= 24 g pure ethanol for male or \>= 12 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 and hormonal replacement therapy, e.g. estrogens, L-thyroxine)
- subjects, who report a frequent occurrence of migraine attacks
- For female subjects with childbearing potential only:
- positive pregnancy test at screening examination
- pregnant or lactating women
- female subjects who do not agree to apply highly effective contraceptive methods Administrative reasons
- 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
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04505787
Start Date
July 24 2020
End Date
September 24 2020
Last Update
October 22 2020
Active Locations (1)
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1
SocraTec R&D GmbH, Clinical Pharmacology Unit
Erfurt, Thuringia, Germany, 99084