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CompletedNCT00702676Updated Jul 16, 2009

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

A Phase 1 interventional study of Quetiapine Fumarate and Quetiapine Fumarate in Healthy Volunteers, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-16.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy Volunteers
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    1

    Quetiapine Fumarate Immediate Release

    Drug: Quetiapine Fumarate

  • Experimental
    2

    Quetiapine Fumarate Extended Release

    Drug: Quetiapine Fumarate

Interventions

  • DrugQuetiapine Fumarate

    Tablet, Oral, once daily

    Also known as: Seroquel IR

  • DrugQuetiapine Fumarate

    Tablet, Oral, once daily

    Also known as: Seroquel XR

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS) 1 hour post dose at Day 1

    Time frame: 1 hour after dose administration at the first dosing day (i.e. Day 1) of each period

  2. Area under the VAS-time curve

    Time frame: Calculated daily from the 13 assessments for 5 days

Secondary outcomes

  1. Pharmacodynamic relationship between maximum VAS and PK concentration

    Time frame: On last day of period (Day 5)

07

Study locations

1 site
  • Research Site
    Baltimore, Maryland, United States
08

References and documents

Publications

  • Datto C, Berggren L, Patel JB, Eriksson H. Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects. Clin Ther. 2009 Mar;31(3):492-502. doi: 10.1016/j.clinthera.2009.03.002. PubMed 19393840 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00702676
Lead sponsor
AstraZeneca
First posted
Jun 20, 2008
Start date
Jul 2008
Primary completion
Aug 2008
Completion
Aug 2008
Last update
Jul 16, 2009

Study contacts

Catherine Datto, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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