drugset / Trial / NCT01642862

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

NCT01642862

Phase 1 Terminated 12 enrolled University of Zurich Stanford University · collab
RandomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2012-07
Primary completion
2013-07
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 20 mg Oral
Subject Simvastatin Small molecule 40 mg Oral

Indications