Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206854
• Other study ID #: FLIP0112
• Secondary ID: 2012-001425-27
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2014
• Last updated: September 10, 2015
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• R-flurbiprofen
200 mg gelatine capsule once orally

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
Gerd Geisslinger	Fraunhofer Institute for Molecular Biology and Applied Ecology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)	assessment of concentration at baseline (0), 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration of study medication	prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration	No
Primary	Time to maximum concentration (Tmax; hours)		prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration	No
Primary	Maximum concentration (Cmax).		prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration	No
Primary	Terminal elimination half-life (t1/2)		prior to administration, 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration	No
Secondary	Number of volunteers with serious and Non serious adverse events	Number and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be documented at V1 (predose and after administration) and at V3 (follow-up visit 8 to 15 days after administration of study medication)	Up to day 15	Yes
Secondary	Analysis of plasma lipid profile	parallel to pK-Analysis plasma lipid profile will be assessed	prior and 30, 60, 90, 120 and 150 minutes and 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration	No