drugset / Trial / NCT01642862
Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration
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
Outcome
Outcome not reported
Stopped (Enrollment): “Low recruitment rate”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simvastatin | Small molecule | 20 mg | Oral |
| Subject | Simvastatin | Small molecule | 40 mg | Oral |