The use of the non-absorbable marker paromomycin sulfate for the evaluation of the gastrointestinal transit

Phase 1

• Conditions: healthy volunteers (administration of antibacterial drug); Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2013-000297-30-BE
• Lead Sponsor: KU Leuven - Drug Delivery & Disposition

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-21
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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 transit by the non-absorbable marker paromomycin sulfate;Secondary Objective: 1) To evaluate influence of prandial state on gastrointestinal transit<br>2) To evaluate influence of transit-mediating agents on gastrointestinal transit;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