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GSK372475 Bioequivalence Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00488098
First Posted: June 19, 2007
Last Update Posted: June 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488098


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00488098     History of Changes
Other Study ID Numbers: SND110117
First Submitted: June 15, 2007
First Posted: June 19, 2007
Last Update Posted: June 4, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:
Healthy Bioequivalence

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms