A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers

NCT01088594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-03-17

No results posted yet for this study

Summary

A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on urinary sodium excretion in 12 healthy male volunteers

Conditions

Interventions

DRUG

pioglitazone/rosiglitazone/placebo

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

DRUG

rosiglitazone/pioglitazone/placebo

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

DRUG

placebo/pioglitazone/rosiglitazone

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

DRUG

pioglitazone/placebo/rosiglitazone

single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg

DRUG

rosiglitazone/placebo/pioglitazone

single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg

DRUG

placebo/rosiglitazone/pioglitazone

single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Claire Nee · Solvay Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01088594 on ClinicalTrials.gov