drugset / Trial / NCT03872596
Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
Phase 1
Completed
58 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
PRA Health Sciences · collab
RandomizedCrossoverOpen-labelBasic science
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.
Timeline
- Start
- 2019-03-27
- Primary completion
- 2019-10-30
- Completion
- 2019-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quetiapine | Small molecule | 25 mg | Oral |
| Subject | Quetiapine | Small molecule | 300 mg | Oral |