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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088594
First Posted: March 17, 2010
Last Update Posted: March 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  Purpose
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

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: pioglitazone/rosiglitazone/placebo Drug: rosiglitazone/pioglitazone/placebo Drug: placebo/pioglitazone/rosiglitazone Drug: pioglitazone/placebo/rosiglitazone Drug: rosiglitazone/placebo/pioglitazone Drug: placebo/rosiglitazone/pioglitazone Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
pioglitazone 45 mg
Drug: pioglitazone/rosiglitazone/placebo
single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
Drug: rosiglitazone/pioglitazone/placebo
single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo
Drug: placebo/pioglitazone/rosiglitazone
single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg
Drug: pioglitazone/placebo/rosiglitazone
single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg
Drug: rosiglitazone/placebo/pioglitazone
single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg
Drug: placebo/rosiglitazone/pioglitazone
single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg
Experimental: 2
Rosiglitazone 8 mg
Drug: pioglitazone/rosiglitazone/placebo
single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
Drug: rosiglitazone/pioglitazone/placebo
single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo
Drug: placebo/pioglitazone/rosiglitazone
single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg
Drug: pioglitazone/placebo/rosiglitazone
single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg
Drug: rosiglitazone/placebo/pioglitazone
single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg
Drug: placebo/rosiglitazone/pioglitazone
single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg
Placebo Comparator: 3
Placebo
Drug: pioglitazone/rosiglitazone/placebo
single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
Drug: rosiglitazone/pioglitazone/placebo
single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo
Drug: placebo/pioglitazone/rosiglitazone
single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg
Drug: pioglitazone/placebo/rosiglitazone
single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg
Drug: rosiglitazone/placebo/pioglitazone
single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg
Drug: placebo/rosiglitazone/pioglitazone
single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088594


Locations
United Kingdom
S337.1.004 Site #
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Claire Nee Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT01088594     History of Changes
Other Study ID Numbers: S337.1.004
2009-017263-42
First Submitted: February 26, 2010
First Posted: March 17, 2010
Last Update Posted: March 17, 2010
Last Verified: March 2010

Keywords provided by Solvay Pharmaceuticals:
urinary sodium excretion
Pioglitazone
Rosiglitazone
Methodological study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs