Influence of gastrointestinal lipid digestion in the absorption of fenofibrate from a lipid-based formulation

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005248-41-BE

Enrollment

Unknown

Registered

2017-04-06

Start date

2017-05-17

Completion date

Unknown

Last updated

2017-08-28

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

Conditions

Healthy volunteers

Interventions

Trade Name: Fenogal 200 mg Lidose Capsule Product Name: Fenogal lidose Pharmaceutical Form: Capsule, hard INN or Proposed INN: FENOFIBRATE CAS Number: 49562-28-9 Concentration unit: mg milligram(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteers age: 18 - 35 years old 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 GI condition - use of medication - pregnancy - frequent exposure to X-rays during the past year - HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of lipid digestion on the gastrointestinal behavior of a fenogal tablet in healthy volunteers and its implications for systemic drug exposure;Secondary Objective: Not applicable;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 ContactDrug Delivery and Disposition

KU Leuven

joachim.brouwers@kuleuven.be+3216330310

Outcome results

None listed

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