pK of a Novel 200 mg Ibuprofen Medicated Plaster

Medherant

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Ibuprofen 200 mg TEPI Medicated Plaster

Drug: Aktren® 200 mg überzogene Tabletten (Ibuprofen)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03694587

MED-IBU-101

Details and patient eligibility

About

This is a Phase I study of the pharmacokinetics of a novel 200 mg Ibuprofen Medicated Plaster. The study will be conducted as a monocentric, open, randomised, single and multiple-dose, two-period, crossover trial in healthy volunteers. A total of 16 healthy volunteers will be randomised.

A wash-out period of 3 days is planned between the two periods. Each of the volunteers will be randomly assigned to one of 2 possible administration sequences.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female subject
Age between 18 and 65 years
Physically and mentally healthy as judged by means of medical and standard laboratory examinations
Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year**) and non-users of other nicotine containing products, confirmed by urine cotinine test
Weight ≥ 60 kg and BMI within the range (including the borders)1 of 18.0 to 30.0 kg/m2
Informed consent given in written form according to chapter 5.4 of the study protocol

Exclusion criteria

Participation in another clinical trial at same time or within the preceding 90 days (calculated from the date of the final examination of the previous study)
Fertile women without reliable contraception method. List of medically accepted contraceptive methods (used at least 4 weeks prior entry screening visit and not to be changed for the duration of the study):
combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
voluntary sterilization (female tubal occlusion).
Randomisation into the present trial more than once
Blood donation or blood loss including plasmapheresis of >500 ml in the last 90 days before entry screening
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at entry screening
History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of entry screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year before entry screening
Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
Regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
Positive drug screening and/or positive alcohol test at entry screening or on hospitalization day -1
Pregnant and/or nursing women. Positive pregnancy test at entry screening or on hospitalization day -1
Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity)
Known allergy to sticking plaster or to the ingredients of the products
History of or active skin disease or dermatologic disease that might interfere with the evaluation of test site reaction
Any history of drug hypersensitivity (especially to the active and inactive ingredients of the ibuprofen preparations and NSAIDs including subjects where attacks of asthma, angioedema, urticaria or rhinitis have been precipitated), or intolerance to any sugar (e.g. fructose, glucose, or lactose)
History of clinically significant food allergies or current significant or perennial allergy at screening
History of autoimmune disorders such as lupus erythematosus
Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other diseases
Clinically significant illness within 4 weeks before entry screening and during the study
Major surgery of the gastrointestinal tract except for appendectomy
Any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug
Intensive UV-light exposure (sunbaths) at the application site or use of tanning beds within 2 weeks before entry screening and during the study
Intake or administration of any systemic or any topical medication (including immune system interfering drugs, OTC medication and especially intake of antacids e.g. aluminum hydroxide, magnesium hydroxide, and simethicone or herbal medication e.g. St. John's wort, kava kava, or use of ointments, gels or patches for skin application, piperine containing products16) as well as hormone replacement therapy within 2 weeks before entry screening and during the study, except single doses of paracetamol given in case of an adverse event (e.g. headache) during the study
Use of topical products without medication at the application sites (including make-up, sunscreen, creams, lotions, powders, alcohol) 7 days prior to entry screening until discharge
Administration of depot injectable solutions or medications with a half-life > 1 week (including study medications) within 6 months before entry screening
Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before entry screening
Medication with drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months prior entry screening
Any method of hair removal (e.g. waxing, shaving, epilating, laser) at the application sites 7 days prior to entry screening until discharge
Subjects with tattoos, sunburn, coloration, open sores or scars (e.g. any burning or stinging) on site(s) of application
History of difficulty in swallowing
Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
Systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg17 at entry screening visit
Heart rate outside the range of 50 to 90 beats/min at entry screening visit
Respiratory rate outside the range of 12-24 breaths/min at entry screening visit
Axillary body temperature outside the interval of 35.5 to 37.1°C at entry screening visit
Any clinically significant abnormality of the resting ECG (12-lead) (i.e. AV block, 2° to 3°, sinus bradycardia, sick sinus syndrome, SA block)
Laboratory values outside normal range with clinical relevance at entry screening visit
Vomiting within the first 4 hours after dosing with oral ibuprofen
Diarrhoea within the first 24 hours after dosing with oral ibuprofen
Special diet due to any reason, e.g. vegetarians
Not fulfilling study specific restrictions given in a study protocol
Engagement in strenuous exercise within 2 weeks prior to check-in (e.g., marathon runners, weight lifters)
Subjects who are known or suspected:
not to comply with the study directives
not to be reliable or trustworthy
not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the inconvenience they may be involved in
subject is a dependent person, e.g. a relative, family member, or member of the investigator's or sponsor's staff
subject is in custody or submitted to an institution due to a judicial order.