pK of a Novel 200 mg Ibuprofen Medicated Plaster

NCT03694587 | Completed Phase 1

• 1 other identifier: MED-IBU-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• AUC(0-12h) of ibuprofen

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

  5 days

• 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

  5 days

• Cmax of Ibuprofen

  Observed maximal concentration after administration

  5 days

Secondary Outcomes (4)

• Tmax after multiple dosing

  5 days

• t½ after multiple dosing

  5days

• λz of total ibuprofen after multiple dosing

  5 days

• AUC(0-inf) after multiple dosing

  5 days

Other Outcomes (8)

• AUC(0-τ) After plaster removal,

  5 days

• Number of subjects with product related Adverse Events

  15 days

• Change in dermal effect score to baseline

  15 days

Study Arms (2)

Test IMP

ACTIVE COMPARATOR

Drug: Ibuprofen 200 mg TEPI Medicated Plaster

Reference IMP

ACTIVE COMPARATOR

Drug: Aktren® 200 mg überzogene Tabletten (Ibuprofen)

Interventions

Ibuprofen 200 mg TEPI Medicated Plaster DRUG

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

Test IMP

Aktren® 200 mg überzogene Tabletten (Ibuprofen) DRUG

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

Reference IMP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medherant Ltd: lead
• Cooperative Clinical Drug Research and Development AG (CCDRD AG): collaborator

Study Sites (1)

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

Sofia, 1504, Bulgaria

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: October 3, 2018
• Study Start: September 25, 2018
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)