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NCT03872596 · ClinicalTrials.gov registry record · Phase 1
Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT03872596: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03872596 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03872596, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study 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.
Primary Outcome
Pharmacokinetic endpoint analysis will be done separately for formulation A and formulation B.
Interventions
- DRUG Seroquel IR 300mg
- DRUG Seroquel IR 25mg
- DRUG Quetiapine Formulation A 300mg
- DRUG Quetiapine Formulation B 300mg
- DRUG Quetiapine Formulation 25mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2019-11-27 |
| Phase | Phase 1 |
What the finished NCT03872596 record still lists
NCT03872596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Seroquel IR 300mg is the first listed.
NCT03872596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03872596 about?
NCT03872596 is a clinical study titled "Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder". 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 ...
What is the current status of trial NCT03872596?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2019-03-27. Estimated completion is 2019-11-27.
What interventions are being tested in trial NCT03872596?
The interventions under investigation include: Seroquel IR 300mg (DRUG), Seroquel IR 25mg (DRUG), Quetiapine Formulation A 300mg (DRUG), Quetiapine Formulation B 300mg (DRUG), Quetiapine Formulation 25mg (DRUG).
Who is sponsoring clinical trial NCT03872596?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03872596's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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