GSK372475 Bioequivalence Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Depressive Disorder

Treatments: Drug: GSK372475

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488098

SND110117

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)