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OpenTrials
Completed

NCT Number: NCT00702676

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine fumarate

Drug

Tablet, Oral, once daily

Other names: Seroquel IR

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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
Jul 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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