the behaviour of fenofibrate in the stomach & small intestine after an oral intake of the drugformulation. At the same time, bloodconcentrations of the drug will be measured and can be correlated with the disposition of the drug in the gastrointestinal tract.

Evaluation of the intraluminal behaviour of fenofibrate in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003815-23-BE

Enrollment

Registered

2013-11-25

Start date

2014-01-16

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (administration of hypolipidemic drug)

Interventions

Trade Name: Lipanthylnano 145mg Product Name: Lipanthylnano Pharmaceutical Form: Tablet INN or Proposed INN: Fenofibrate CAS Number: 49562-28-9 Current Sponsor code: FENO Other descriptive name: FENOF

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteers age between 18-40 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: disease, acute/ chronic gastrointestinal tract disease, use of medication, pregnancy, frequent exposure to X-ray, HIV, HBV or HCV

Design outcomes

Primary

Measure	Time frame
Main Objective: Characterize how different formulations of fenofibrate react in the human body by aspirating stomach fluids and duodenal fluids by using catheters. The drug in the fluids will than be analysed. Further blood samples will be taken of the volunteers to see how many drug will be absorbed.;Secondary Objective: Trying to find any kind of correlation between exposure of the drug and how it reacts in the gastrointestinal tract in human volunteers;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: Characterize how different formulations of fenofibrate react in the human body by aspirating stomach fluids and duodenal fluids by using catheters. The drug in the fluids will than be analysed. Further blood samples will be taken of the volunteers to see how many drug will be absorbed.;Secondary Objective: Trying to find any kind of correlation between exposure of the drug and how it reacts in the gastrointestinal tract in human volunteers;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactBart Hens

KU Leuven

bart.hens@pharm.kuleuven.be+3216330302

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026