Quetiapine Fumarate Immediate Release (IR) Versus Extended Release (XR) Dose Escalation Comparison

A Double-blind, Double-dummy, Randomized, Crossover Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) During Initial Dose Escalation in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702676

Enrollment

Registered

2008-06-20

Start date

2008-07-31

Completion date

2008-08-31

Last updated

2009-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Brief summary

This study will compare the tolerability of Quetiapine Fumarate immediate release formulation and Quetiapine Fumarate extended release formulation during initial dose escalation in healthy volunteers.

Interventions

DRUGQuetiapine Fumarate

Tablet, Oral, once daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Provision of informed consent prior to any study specific procedures * Weight of at least 50 kg

Exclusion criteria

* A history or presence of neurological, hematological, psychiatric, gastrointestinal, hepatic, pulmonary, or renal disease or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs * Positive test results for alcohol or drugs of abuse * Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

Design outcomes

Primary

Measure	Time frame
Visual Analog Scale (VAS) 1 hour post dose at Day 1	1 hour after dose administration at the first dosing day (i.e. Day 1) of each period
Area under the VAS-time curve	Calculated daily from the 13 assessments for 5 days

Secondary

Measure	Time frame
Pharmacodynamic relationship between maximum VAS and PK concentration	On last day of period (Day 5)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026