GSK372475 Bioequivalence Study

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 15, 2007
Last updated: May 31, 2012
Last verified: February 2011

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

Condition Intervention Phase
Healthy Subjects
Depressive Disorder
Drug: GSK372475
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Parallel Groups, Bioequivalence Study to Compare a Single Oral Dose of GSK372475B or GSK372475C in Male and Female Healthy Volunteers.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: July 2007
Intervention Details:
    Drug: GSK372475
    Other Name: GSK372475

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00488098

Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M1L 4S4
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00488098     History of Changes
Other Study ID Numbers: SND110117
Study First Received: June 15, 2007
Last Updated: May 31, 2012
Health Authority: Canada: Therapeutic Products Directorate

Keywords provided by GlaxoSmithKline:
Healthy Bioequivalence

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on April 17, 2014