NCT01642862

Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration

A Phase I, Randomized, Open Label, Mono-centered, Prospective Study to Evaluate the Pharmacokinetics of Different Formulations and Doses of Simvastatin in Healthy Subjects and in Subjects With Celiac Disease in Remission

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The inter- and intra-variability in the pharmacokinetic parameters of different formulations and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission will be evaluated. Additionally, baseline values of pharmacokinetic parameters of simvastatin for both study groups will be determined.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DRUG	Simvastatin	Comparison of pharmacokinetic parameters of different formulations (liquid vs tablet) and doses (20 or 40 mg) of simvastatin after single oral administration of the drug

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2014-02-01
• First posted: 2012-07-17
• Last updated: 2015-06-03

Locations

1 site across 1 country: Switzerland