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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088594

Enrollment

Registered

2010-03-17

Start date

2010-02-28

Completion date

2010-03-31

Last updated

2010-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

urinary sodium excretion, Pioglitazone, Rosiglitazone, Methodological study

Brief 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

Interventions

DRUGpioglitazone/rosiglitazone/placebo

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

DRUGrosiglitazone/pioglitazone/placebo

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

DRUGplacebo/pioglitazone/rosiglitazone

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

DRUGpioglitazone/placebo/rosiglitazone

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

DRUGrosiglitazone/placebo/pioglitazone

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

DRUGplacebo/rosiglitazone/pioglitazone

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Volunteers with Body Mass Index 18.0-28.0 kg/m2

Exclusion criteria

Clinically relevant medical history

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026