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

Solvay Pharmaceuticals12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

pioglitazone/rosiglitazone/placeboDRUG

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

rosiglitazone/pioglitazone/placeboDRUG

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

placebo/pioglitazone/rosiglitazoneDRUG

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

S337.1.004 Site #

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 0-6 hours

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

Time frame: 0-6 hours

Secondary Outcomes

Sodium clearance on Day 1 of each study period

Time frame: 0-6 hours

Creatinine clearance calculated on Day 1 of each study period

Time frame: 0-6 hours

Data from ClinicalTrials.gov

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