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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088594
• Other study ID #: S337.1.004
• Secondary ID: 2009-017263-42
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2010
• Last updated: March 16, 2010
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: MHRA - Medicines and Healthcare products Regulatory Agency UK
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• pioglitazone/rosiglitazone/placebo
single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
• rosiglitazone/pioglitazone/placebo
single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo
• placebo/pioglitazone/rosiglitazone
single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg
• pioglitazone/placebo/rosiglitazone
single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg
• rosiglitazone/placebo/pioglitazone
single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg
• placebo/rosiglitazone/pioglitazone
single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

Locations

Country	Name	City	State
United Kingdom	S337.1.004 Site #	London

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-course urinary sodium excretion calculated on the Day 1 of each study period		0-6 hours	No
Primary	Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period		0-6 hours	No
Secondary	Sodium clearance on Day 1 of each study period		0-6 hours	No
Secondary	Creatinine clearance calculated on Day 1 of each study period		0-6 hours	No