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

Phase 1

Terminated

• Conditions: Celiac Disease
• Interventions: Drug: Simvastatin

• Registration Number: NCT01642862
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Primary Completion: 2013-07
• Study Completion: 2014-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid formulation of Simvastatin	Simvastatin	-
Tablet formulation of Simvastatin	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of simvastatin	0, 15, 30, 60, 90, 120, 180 minutes post-dose	Determination of time-dependent concentrations of simvastatin in collected serum of each subject following oral administration of two different formulations and two different doses of simvastatin

Trial Locations

Locations (1)

University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology; 🇨🇭 Zurich, ZH, Switzerland