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OpenTrials
Completed

NCT Number: NCT01088594

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

S337.1.004 Site #

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 0-6 hours

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

    Time frame: 0-6 hours

Secondary outcomes

  1. Sodium clearance on Day 1 of each study period

    Time frame: 0-6 hours

  2. Creatinine clearance calculated on Day 1 of each study period

    Time frame: 0-6 hours

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 17, 2010
Registry last updated
Mar 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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