NCT03872596

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

A Phase 1, 2-Part, Open-Label, Randomized, Crossover Pilot Trial to Assess the Relative Bioavailability of Quetiapine Versus Seroquel® 300-mg Oral Tablets in Subjects With Schizophrenia or Bipolar Disorder and 25-mg Oral Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part trial. The primary objective of Part A is to estimate the ratio of geometric means of pharmacokinetic (PK) parameters and their within-subject variability for the 300mg quetiapine tablet formulation A and the 300mg quetiapine tablet formulation B compared to 300mg Seroquel. The primary objective of Part B is to estimate the ratio of geometric means of PK parameters and their within-subject variability for the selected tablet formulation from Part A of 25mg quetiapine compared to 25mg Seroquel.

Conditions

• Bipolar Disorder
• Schizophrenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-27
• Primary completion: 2019-10-30
• Completion: 2019-11-27
• First posted: 2019-03-13
• Last updated: 2020-09-02

Locations

1 site across 1 country: United States