GSK372475 Bioequivalence Study

NCT ID: NCT00488098

Last Updated: 2012-06-04

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.

Detailed Description

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Conditions

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Healthy Subjects Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GSK372475

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Males/Females aged 18-45 years
* Non-smokers
* BMI 19-30 kg.m2
* QTc\<450msec

Exclusion Criteria

* Use of oral contraception
* Positive breath alcohol and drug screen
* Regular alcohol consumption
* Current psychiatric illness or within 1 year.
* History of GI, hepatic or renal disease
* Uncontrolled hypertension
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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SND110117

Identifier Type: -

Identifier Source: org_study_id

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