The influence of the body on the fate of sulindac in healthy volunteers

The intestinal disposition of sulindac in healthy volunteers

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001496-36-BE

Enrollment

Registered

2019-06-04

Start date

2019-07-15

Completion date

Unknown

Last updated

2020-09-21

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: Arthrocine 200mg 30 Tabletten Product Name: Arthrocine Pharmaceutical Form: Tablet INN or Proposed INN: SULINDAC CAS Number: 38194-50-2 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers age: 20 - 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: Allergic to sulindac or NSAID Acute/chronic gastro-intestinal disease diabetic, cardiovascular disease, pulmonitis, or renal disease (possible) pregnancy medicine (contraception excluded) smoker HIV, HBV or HVC contamination

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the disposition and bioavailability of Arthrocine at the level of the colon and blood respectively;Secondary Objective: Not applicable;Primary end point(s): Insight into the disposition of sulindac after analysis of both biopts and colonic fluids of healthy volunteers;Timepoint(s) of evaluation of this end point: 11/2020	—

Secondary

Measure	Time frame
Secondary end point(s): No secundary end points;Timepoint(s) of evaluation of this end point: no timepoint	—

Countries

Belgium

Contacts

Public ContactDrug Delivery & Disposition

KU Leuven

glenn.lemmens@kuleuven.be

Outcome results

None listed

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