GSK372475 Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00488098
First received: June 15, 2007
Last updated: May 31, 2012
Last verified: February 2011
  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
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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 27, 2014