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HealthyPhase 1NCT03694587

pK of a Novel 200 mg Ibuprofen Medicated Plaster

A Phase 1 study testing Ibuprofen 200 mg TEPI Medicated Plaster and Aktren® 200 mg überzogene Tabletten (Ibuprofen) in people with Healthy, run by Medherant Ltd at 1 site in Bulgaria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ibuprofen 200 mg TEPI Medicated Plaster and Aktren® 200 mg überzogene Tabletten (Ibuprofen)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteBulgaria
Study dates
25 Sep 2018to 18 Oct 2018
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 50Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Bulgaria1 site

  • Clinic of Clinical Pharmacology and Therapeutics University Multidisciplinary Hospital for Active Treatment 'Tsaritsa Ioanna-ISUL' EAD

    Sofia, 1504

Other trials in Bulgaria

About this study

Official title: A Single and Multiple Dose, Randomised, Open-label, Cross-over, Healthy Volunteer, Phase I Study of the Pharmacokinetics of a Novel 200 mg Ibuprofen Medicated Plaster

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.

Conditions
Healthy
Being tested
Ibuprofen 200 mg TEPI Medicated Plaster, Aktren® 200 mg überzogene Tabletten (Ibuprofen)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibuprofen 200 mg TEPI Medicated PlasterDrug

    Ibuprofen 200mg TEPI medicated plaster applied to the upper back daily for 24 hours for 5 days

  • Aktren® 200 mg überzogene Tabletten (Ibuprofen)Drug

    one dose of Aktren® 200 mg überzogene Tabletten (Ibuprofen tablet)

Study groups in NCT03694587
Study groupRoleWhat they receive
Test IMPActive comparatorNot described
Receives: Drug: Ibuprofen 200 mg TEPI Medicated Plaster
Reference IMPActive comparatorNot described
Receives: Drug: Aktren® 200 mg überzogene Tabletten (Ibuprofen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC(0-12h) of ibuprofen

    Area under the concentration/time curve, from time 0 h to 12 h

    Measured: 5 days

  2. AUC(0-t) of Ibuprofen

    Area under the concentration/time curve, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t

    Measured: 5 days

  3. Cmax of Ibuprofen

    Observed maximal concentration after administration

    Measured: 5 days

Secondary outcomes (4)

  1. Tmax after multiple dosing

    Observed time point of maximal concentration

    Measured: 5 days

  2. t½ after multiple dosing

    Plasma concentration half-life calculated according to t1/2=ln(2)/ λz

    Measured: 5days

  3. λz of total ibuprofen after multiple dosing

    Terminal rate constant (slowest rate constant of the disposition) negative of the slope of a log-linear regression of the unweighted data considering the last concentration-time points ≥ LLOQ

    Measured: 5 days

  4. AUC(0-inf) after multiple dosing

    Area under the concentration/time curve, from time 0 h extrapolated to infinity (AUC(0-∞) = AUC(0-t) + Clast/λz where Clast is the last concentration above the limit of quantification and λz is the terminal elimination constant)

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start25 Sep 2018
  3. Primary completion18 Oct 2018
  4. Study completion18 Oct 2018

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03694587
Sponsor's protocol ID
MED-IBU-101
Status last verified
Apr 2019
First submitted
16 Aug 2018
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuprofen 200 mg TEPI Medicated Plaster and Aktren® 200 mg überzogene Tabletten (Ibuprofen) in people with Healthy, run by Medherant Ltd at 1 site in Bulgaria.

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 6 inclusion and 50 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 16 Apr 2019. 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 Bulgaria. 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?

AUC(0-12h) of ibuprofen (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694587.

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 16 Apr 2019.

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