Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 27, 2019

Primary Completion Date

October 30, 2019

Study Completion Date

November 27, 2019

Conditions
Bipolar DisorderSchizophrenia
Interventions
DRUG

Seroquel IR 300mg

Administered during Part A, administered orally BID with water, over 5 days.

DRUG

Seroquel IR 25mg

Administered during Part B, as a single, 25mg dose taken with water.

DRUG

Quetiapine Formulation A 300mg

Administered during Part A, administered orally BID with water, over 5 days.

DRUG

Quetiapine Formulation B 300mg

Administered during Part A, administered orally BID with water, over 5 days.

DRUG

Quetiapine Formulation 25mg

Administered during Part B, as a single, 25mg dose taken with water.

Trial Locations (1)

90806

Collaborative Neurosciences Network, LLC, Long Beach

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY