The influence of the human body on the fate of Celebrex for the prevention/treatment of colorectal cancer: plasma concentration and elimination of Celebrex in healthy volunteers

Pharmacokinetics of Celebrex for the prevention/treatment of colorectal cancer: Systemic pharmacokinetics and elimination of Celebrex in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000131-13-BE

Enrollment

Registered

2017-04-20

Start date

2017-05-11

Completion date

Unknown

Last updated

2020-04-06

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

Conditions

Colorectal cancer

Interventions

Trade Name: CELEBREX 200 mg harde capsules Product Name: CELEBREX 200 mg harde capsules Product Code: 15L18 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Celecoxib CAS Number: 169590-42-5 O

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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: allergic to Celecoxib or NSAID acute/chronic gastro-intestinal disease diabetic, cardiovascular disease, pulmonitis, or renal disease (possible) pregnancy medicine (contraception excluded) smoker HIV, HBV or HCV contamination

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the pharmacokinetics of Celecoxib for the prevention/treatment of colorectal cancer ;Secondary Objective: Not applicable;Primary end point(s): The pharmacokinetic profiling of Celecoxib following oral administration in healthy volunteers ;Timepoint(s) of evaluation of this end point: 10/2019	—

Secondary

Measure	Time frame
Secondary end point(s): No secondary endpoint;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