Gastrointestinal behavior of itraconazole in healthy volunteers

Phase 1

• Conditions: healthy volunteers (administration of antifungal drug); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-005928-17-BE
• Lead Sponsor: Katholieke Universiteit Leuven - Pharmacotechnology and Biopharmacy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-19
• Study Completion: 2016-05-04
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

- healthy volunteers
- age between 18 and 35
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

- pregnancy
- disease
- use of medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the gastrointestinal behavior and absorption of itraconazole.;Secondary Objective: - To compare 2 commercialized oral formulations of itraconazole (capsule versus solution).<br>- To compare fasted versus fed state.;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable