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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

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 period

Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period

Secondary outcome:

Sodium clearance on Day 1 of each study period

Creatinine 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

Page last updated: August 20, 2015

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