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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: pioglitazone/rosiglitazone/placebo
* Drug: rosiglitazone/pioglitazone/placebo
* Drug: placebo/pioglitazone/rosiglitazone
* Drug: pioglitazone/placebo/rosiglitazone
* Drug: rosiglitazone/placebo/pioglitazone
* Drug: placebo/rosiglitazone/pioglitazone


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>pioglitazone 45 mg | Drug: pioglitazone/rosiglitazone/placebo<br>* single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo<br>Drug: rosiglitazone/pioglitazone/placebo<br>* single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo<br>Drug: placebo/pioglitazone/rosiglitazone<br>* single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg<br>Drug: pioglitazone/placebo/rosiglitazone<br>* single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg<br>Drug: rosiglitazone/placebo/pioglitazone<br>* single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg<br>Drug: placebo/rosiglitazone/pioglitazone<br>* single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg<br>|
| Experimental: 2<br>Rosiglitazone 8 mg | Drug: pioglitazone/rosiglitazone/placebo<br>* single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo<br>Drug: rosiglitazone/pioglitazone/placebo<br>* single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo<br>Drug: placebo/pioglitazone/rosiglitazone<br>* single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg<br>Drug: pioglitazone/placebo/rosiglitazone<br>* single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg<br>Drug: rosiglitazone/placebo/pioglitazone<br>* single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg<br>Drug: placebo/rosiglitazone/pioglitazone<br>* single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg<br>|
| Placebo Comparator: 3<br>Placebo | Drug: pioglitazone/rosiglitazone/placebo<br>* single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo<br>Drug: rosiglitazone/pioglitazone/placebo<br>* single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo<br>Drug: placebo/pioglitazone/rosiglitazone<br>* single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg<br>Drug: pioglitazone/placebo/rosiglitazone<br>* single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg<br>Drug: rosiglitazone/placebo/pioglitazone<br>* single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg<br>Drug: placebo/rosiglitazone/pioglitazone<br>* single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary sodium excretion, Pioglitazone, Rosiglitazone, Methodological study