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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-000297-30-BE
Enrollment
10
Registered
2013-02-21
Start date
2013-03-21
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

healthy volunteers (administration of antibacterial drug)

Interventions

Trade Name: Gabbroral 250 mg tablets Product Name: Gabbroral Pharmaceutical Form: Tablet INN or Proposed INN: Paromomycin Sulfate CAS Number: 1263-89-4 Current Sponsor code: PM Other descriptive name:

Sponsors

KU Leuven - Drug Delivery & Disposition
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - pregnancy - disease - use of medication

Design outcomes

Primary

MeasureTime frame
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 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

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

Countries

Belgium

Contacts

Public ContactDrug Delivery & Disposition

KU Leuven

bart.hens@pharm.kuleuven.be3216330302

Outcome results

None listed

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