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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 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 58 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03872596
The ClinicalTrials.gov registry entry for NCT03872596 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Seroquel IR 300mg is the first listed.
NCT03872596 reports 0 study locations.
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.
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