GSK372475 Bioequivalence Study

Phase 1CompletedNCT00488098

GlaxoSmithKline66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects Depressive Disorder

Interventions

GSK372475DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax

Time frame: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.

Secondary Outcomes

Adverse events

Time frame: all visits

vitals (all visits) + ECG

Time frame: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.

labs

Time frame: at screening and 2 weeks post dose

Data from ClinicalTrials.gov

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