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
Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: pioglitazone/rosiglitazone/placebo (Drug); rosiglitazone/pioglitazone/placebo (Drug); placebo/pioglitazone/rosiglitazone (Drug); pioglitazone/placebo/rosiglitazone (Drug); rosiglitazone/placebo/pioglitazone (Drug); placebo/rosiglitazone/pioglitazone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s): Claire Nee, Study Director, Affiliation: Solvay Pharmaceuticals
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
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Time-course urinary sodium excretion calculated on the Day 1 of each study periodTime-course absolute urinary sodium excretion calculated on the Day 1 of each study period
Secondary outcome: Sodium clearance on Day 1 of each study periodCreatinine clearance calculated on Day 1 of each study period
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria Volunteers with Body Mass Index 18. 0-28. 0 kg/m2 Exclusion Criteria
Clinically relevant medical history
Locations and Contacts
S337.1.004 Site #, London, United Kingdom
Additional Information
Starting date: February 2010
Last updated: March 16, 2010
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