Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT00702676

Start Date

July 1 2008

End Date

August 1 2008

Last Update

July 16 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Research Site

Baltimore, Maryland, United States