Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
Information source: Goethe University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: R-flurbiprofen (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Gerd Geisslinger Official(s) and/or principal investigator(s): Gerd Geisslinger, Prof MD, Principal Investigator, Affiliation: Goethe University
Overall contact: Tanja Rossmanith, Phd, Phone: 00 49 69 67724, Ext: 182, Email: tanja.rossmanith@ime.fraunhofer.de
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.
Clinical Details
Official title: Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Area under the curve (AUC)Time to maximum concentration (Tmax; hours) Maximum concentration (Cmax). Terminal elimination half-life (t1/2)
Secondary outcome: Number of volunteers with serious and Non serious adverse eventsAnalysis of plasma lipid profile
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Tanja Rossmanith, Phd, Phone: 00 49 69 67724, Ext: 182, Email: tanja.rossmanith@ime.fraunhofer.de
Johann Wolfgang Goethe University Hospital, Frankfurt 60528, Germany; Recruiting Jochen Graff, MD, Phone: 00 49 69 6301, Ext: 5826, Email: graff@em.uni-frankfurt.de Jochen Graff, MD, Principal Investigator
Additional Information
Starting date: June 2014
Last updated: August 11, 2014
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