Clinical trial NCT02206854: Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
Official title: Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmakokinetic
capsules
R-Flurbiprofen
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
First posted: 2014-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study R-flurbiprofen, will be available as gelatine capsules.

This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood samples at different time points. To assess the safety of the administered capsules adverse events will be documented.

Analysis of lipid signaling molecules in plasma will be done to assess the role of this molecules as variable for therapeutic effects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 18 to 65 years
* Body mass index (BMI) between 18.5 und 30 kg/m2
* Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
* Subject has no evidence of clinically significant abnormality on echocardiogram (ECG) performed at screening visit and/or prior to administration of the study drug
* Non-Smoker
* Subjects providing informed consent

Exclusion Criteria:

* Subjects with known hypersensitivity to study medication
* Subjects who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
* Subjects with a history of peptic ulcer disease and/or gastrointestinal bleeding
* Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
* History or evidence of active malignancy within the 24 months prior to entry.
* Subject has a history of fainting during blood draws.
* Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) in the last 4 weeks
* Subject is currently a regular user (including "recreational use) of illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years.
* Active or history of drug abuse,
* Chronic or acute renal, hepatic or metabolic disorder
* Participation in a clinical study within 30 days prior to screening
* Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
* Subject is unable to refrain from or anticipates the use of any medication, (including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug until the follow-up visit.
* Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
* There is any concern of the investigator regarding the safe participation of the subject in the study or for any other reason, the investigator considers the subject inappropriate for participation in the study.

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
measure: Time to maximum concentration (Tmax; hours)
timeFrame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
measure: Maximum concentration (Cmax).
timeFrame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
measure: Terminal elimination half-life (t1/2)
timeFrame: prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Secondary outcomes:
measure: Number of volunteers with serious and Non serious adverse events
timeFrame: Up to day 15
measure: Analysis of plasma lipid profile
timeFrame: prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University Hospital
Study officials:
affiliation: Goethe University
name: Gerd Geisslinger, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: