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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone

• Registration Number: NCT01088594
• Lead Sponsor: Solvay Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted QC: 2010-03-16
• Last Update Submitted: 2010-03-16
• Study First Posted: 2010-03-17
• Last Update Posted: 2010-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	pioglitazone/rosiglitazone/placebo	pioglitazone 45 mg
1	rosiglitazone/pioglitazone/placebo	pioglitazone 45 mg
1	placebo/pioglitazone/rosiglitazone	pioglitazone 45 mg
1	pioglitazone/placebo/rosiglitazone	pioglitazone 45 mg
1	rosiglitazone/placebo/pioglitazone	pioglitazone 45 mg
1	placebo/rosiglitazone/pioglitazone	pioglitazone 45 mg
2	pioglitazone/rosiglitazone/placebo	Rosiglitazone 8 mg
2	rosiglitazone/pioglitazone/placebo	Rosiglitazone 8 mg
2	placebo/pioglitazone/rosiglitazone	Rosiglitazone 8 mg
2	pioglitazone/placebo/rosiglitazone	Rosiglitazone 8 mg
2	rosiglitazone/placebo/pioglitazone	Rosiglitazone 8 mg
2	placebo/rosiglitazone/pioglitazone	Rosiglitazone 8 mg
3	pioglitazone/rosiglitazone/placebo	Placebo
3	rosiglitazone/pioglitazone/placebo	Placebo
3	placebo/pioglitazone/rosiglitazone	Placebo
3	pioglitazone/placebo/rosiglitazone	Placebo
3	rosiglitazone/placebo/pioglitazone	Placebo
3	placebo/rosiglitazone/pioglitazone	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

S337.1.004 Site #; 🇬🇧 London, United Kingdom