This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Intervention Model: Parallel Assignment
Masking: None (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.

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by GlaxoSmithKline:
Healthy Bioequivalence

Additional relevant MeSH terms:
Depressive Disorder
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on August 22, 2017