Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
Status:
Completed
Trial end date:
2019-11-27
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.