Gastrointestinal behavior of simvastatin in healthy volunteers

Gastrointestinal behavior of simvastatin in healthy volunteers - Gastrointestinal behavior of simvastatin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001715-76-BE

Enrollment

Registered

2013-07-30

Start date

2013-09-05

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

Healthy volunteers (administration of a hypolipidemic drug)

Interventions

Trade Name: Zocor 40mg tablets Product Name: Simvastatin Pharmaceutical Form: Tablet

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 - regular exposure to X-radiation last year

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the gastrointestinal behavior and absorption of simvastatin.;Secondary Objective: To compare fasted versus fed state.;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

sophie.geboers@pharm.kuleuven.be3216330301

Outcome results

None listed

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