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

NCT01088594 — Phase 1, Completed, 12 participants, Solvay Pharmaceuticals

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT01088594
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none
Enrollment	12 (Actual)
Sponsor	Solvay Pharmaceuticals (Industry)
Conditions	Type 2 Diabetes Mellitus
Interventions	pioglitazone/rosiglitazone/placebo, rosiglitazone/pioglitazone/placebo, placebo/pioglitazone/rosiglitazone, pioglitazone/placebo/rosiglitazone, rosiglitazone/placebo/pioglitazone, placebo/rosiglitazone/pioglitazone (Drug)
Dates	start 2010-02-01, primary completion 2010-03-01, completion 2010-03-01, first posted 2010-03-17, last updated 2010-03-17
Locations	1 site in United Kingdom

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone	pioglitazone 45 mg
2	Experimental	Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone	Rosiglitazone 8 mg
3	Placebo comparator	Drug: pioglitazone/rosiglitazone/placebo; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: placebo/rosiglitazone/pioglitazone	Placebo

pioglitazone/rosiglitazone/placebo (Drug): single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
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

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
S337.1.004 Site #	London	United Kingdom

+Investigators

Claire Nee, Study director, Solvay Pharmaceuticals

+Funding

NIH grants: 2009