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OpenTrials
Completed

NCT Number: NCT00488098

GSK372475 Bioequivalence Study

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

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Key information

Conditions

Healthy Subjects Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Toronto, Ontario, M1L 4S4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK372475

Drug

Primary outcomes

  1. 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 outcomes

  1. Adverse events

    Time frame: all visits

  2. vitals (all visits) + ECG

    Time frame: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.

  3. labs

    Time frame: at screening and 2 weeks post dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
First posted
Jun 19, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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