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

NCT01642862 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-06-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gerhard Rogler, Prof MD PhD · University Hospital Zurich, Gastroenterology and Hepatology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-07-31
Completion
2014-02-28

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01642862 on ClinicalTrials.gov