GSK372475 Bioequivalence Study

An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00488098

Enrollment

Registered

2007-06-19

Start date

2007-07-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Healthy Subjects

Keywords

Healthy Bioequivalence

Brief summary

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

Interventions

DRUGGSK372475

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax	at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.

Secondary

Measure	Time frame
Adverse events	all visits
vitals (all visits) + ECG	at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
labs	at screening and 2 weeks post dose

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026