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

March 16, 2010 updated by: Solvay Pharmaceuticals
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
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
Experimental: 1
pioglitazone 45 mg
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
Experimental: 2
Rosiglitazone 8 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time-course urinary sodium excretion calculated on the Day 1 of each study period
Time Frame: 0-6 hours
0-6 hours
Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period
Time Frame: 0-6 hours
0-6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Sodium clearance on Day 1 of each study period
Time Frame: 0-6 hours
0-6 hours
Creatinine clearance calculated on Day 1 of each study period
Time Frame: 0-6 hours
0-6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Investigators

  • Study Director: Claire Nee, Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Estimate)

March 17, 2010

Last Update Submitted That Met QC Criteria

March 16, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S337.1.004
  • 2009-017263-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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