GSK372475 Bioequivalence Study

Healthy Subjects Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488098
• Other study ID #: SND110117
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2007
• Last updated: May 31, 2012
• Start date: July 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Therapeutic Products Directorate
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Healthy Subjects

Intervention

Drug:
• GSK372475

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax		at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.
Secondary	Adverse events		all visits
Secondary	vitals (all visits) + ECG		at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.
Secondary	labs		at screening and 2 weeks post dose