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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01088594
First received: February 26, 2010
Last updated: March 16, 2010
Last verified: March 2010
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sodium clearance on Day 1 of each study period [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]
  • Creatinine clearance calculated on Day 1 of each study period [ Time Frame: 0-6 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01088594     History of Changes
Other Study ID Numbers: S337.1.004, 2009-017263-42
Study First Received: February 26, 2010
Last Updated: March 16, 2010
Health Authority: United Kingdom: MHRA - Medicines and Healthcare products Regulatory Agency UK

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014