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

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: placebo/rosiglitazone/pioglitazone; Drug: pioglitazone/placebo/rosiglitazone; Drug: rosiglitazone/pioglitazone/placebo; Drug: placebo/pioglitazone/rosiglitazone; Drug: rosiglitazone/placebo/pioglitazone; Drug: pioglitazone/rosiglitazone/placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01088594

2009-017263-42

S337.1.004

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

12 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

pioglitazone 45 mg

Treatment:

Drug: pioglitazone/rosiglitazone/placebo

Drug: rosiglitazone/placebo/pioglitazone

Drug: placebo/pioglitazone/rosiglitazone

Drug: rosiglitazone/pioglitazone/placebo

Drug: placebo/rosiglitazone/pioglitazone

Drug: pioglitazone/placebo/rosiglitazone

2

Experimental group

Description:

Rosiglitazone 8 mg

Treatment:

Drug: pioglitazone/rosiglitazone/placebo

Drug: rosiglitazone/placebo/pioglitazone

Drug: placebo/pioglitazone/rosiglitazone

Drug: rosiglitazone/pioglitazone/placebo

Drug: placebo/rosiglitazone/pioglitazone

Drug: pioglitazone/placebo/rosiglitazone

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: pioglitazone/rosiglitazone/placebo

Drug: rosiglitazone/placebo/pioglitazone

Drug: placebo/pioglitazone/rosiglitazone

Drug: rosiglitazone/pioglitazone/placebo

Drug: placebo/rosiglitazone/pioglitazone

Drug: pioglitazone/placebo/rosiglitazone