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

NCT02206854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-09-11

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

R-flurbiprofen

200 mg gelatine capsule once orally

Sponsors & Collaborators

  • Fraunhofer Institute for Translational Medicine and Pharmacology ITMP

    collaborator OTHER

  • Gerd Geisslinger

    lead OTHER

Principal Investigators

  • Gerd Geisslinger, Prof MD · Goethe University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02206854 on ClinicalTrials.gov