DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 events

Analysis 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017