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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017263-42 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | pioglitazone 45 mg |
|
| 2 | Experimental | Rosiglitazone 8 mg |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone/rosiglitazone/placebo | Drug | single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo |
|
| 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 |
| 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 |
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Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history
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| Name | Affiliation | Role |
|---|---|---|
| Claire Nee | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S337.1.004 Site # | London | United Kingdom |
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| rosiglitazone/pioglitazone/placebo | Drug | single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo |
|
| placebo/pioglitazone/rosiglitazone | Drug | single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg |
|
| pioglitazone/placebo/rosiglitazone | Drug | single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg |
|
| rosiglitazone/placebo/pioglitazone | Drug | single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg |
|
| placebo/rosiglitazone/pioglitazone | Drug | single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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