Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014