Determination of drug amounts in the duodenum with the help of a catheter

Determination of free concentrations of paracetamol, amxocilline and valsartan in the duodenum by using a capillary diffusion catheter

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002897-10-BE

Enrollment

Unknown

Registered

2016-08-18

Start date

2016-09-14

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 human volunteers, investigation of free drug concentrations in the duodenum

Interventions

Trade Name: Perdolan Product Name: Perdolan Pharmaceutical Form: Syrup INN or Proposed INN: Paracetamol CAS Number: 103-90-2 Other descriptive name: PARACETAMOL Concentration unit: mg milligram(s) Con

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 5 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- pregnancyfrequent exposure to X-rays during the past year- HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: Study free drug concentrations in the duodenum after oral administration of a drug with the help of a capillairy diffusion catheter.;Secondary Objective: Non 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

jari.rubbens@kuleuven.be

Outcome results

None listed

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