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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

NCT ID: NCT01088594

Last Updated: 2010-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1

pioglitazone 45 mg

Group Type EXPERIMENTAL

pioglitazone/rosiglitazone/placebo

Intervention Type DRUG

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

rosiglitazone/pioglitazone/placebo

Intervention Type DRUG

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

placebo/pioglitazone/rosiglitazone

Intervention Type DRUG

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

pioglitazone/placebo/rosiglitazone

Intervention Type DRUG

single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg

rosiglitazone/placebo/pioglitazone

Intervention Type DRUG

single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg

placebo/rosiglitazone/pioglitazone

Intervention Type DRUG

single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

2

Rosiglitazone 8 mg

Group Type EXPERIMENTAL

pioglitazone/rosiglitazone/placebo

Intervention Type DRUG

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

rosiglitazone/pioglitazone/placebo

Intervention Type DRUG

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

placebo/pioglitazone/rosiglitazone

Intervention Type DRUG

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

pioglitazone/placebo/rosiglitazone

Intervention Type DRUG

single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg

rosiglitazone/placebo/pioglitazone

Intervention Type DRUG

single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg

placebo/rosiglitazone/pioglitazone

Intervention Type DRUG

single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

3

Placebo

Group Type PLACEBO_COMPARATOR

pioglitazone/rosiglitazone/placebo

Intervention Type DRUG

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

rosiglitazone/pioglitazone/placebo

Intervention Type DRUG

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

placebo/pioglitazone/rosiglitazone

Intervention Type DRUG

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

pioglitazone/placebo/rosiglitazone

Intervention Type DRUG

single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg

rosiglitazone/placebo/pioglitazone

Intervention Type DRUG

single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg

placebo/rosiglitazone/pioglitazone

Intervention Type DRUG

single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

Interventions

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pioglitazone/rosiglitazone/placebo

single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo

Intervention Type DRUG

rosiglitazone/pioglitazone/placebo

single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo

Intervention Type DRUG

placebo/pioglitazone/rosiglitazone

single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg

Intervention Type DRUG

pioglitazone/placebo/rosiglitazone

single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg

Intervention Type DRUG

rosiglitazone/placebo/pioglitazone

single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg

Intervention Type DRUG

placebo/rosiglitazone/pioglitazone

single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria Volunteers with Body Mass Index 18.0-28.

Exclusion Criteria

0 kg/m2 Exclusion Criteria Clinically relevant medical history
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Claire Nee

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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S337.1.004 Site #

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2009-017263-42

Identifier Type: -

Identifier Source: secondary_id

S337.1.004

Identifier Type: -

Identifier Source: org_study_id

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