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OpenTrials
Completed

NCT Number: NCT00919607

Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged 18 through 60 years inclusive
  • Schizophrenia diagnosis
  • Body Mass Index (BMI) 20-27 kg/m2 (inclusive)
  • Provision of written informed consent before initiation of any study

Exclusion criteria

  • AIDS & hepatitis B
  • History of seizure disorder
  • History of episodic,idiopathic orthostatic hypotension

Treatment and study plan

quetiapine fumarate extended-release

Drug

200mg,oral,single dose

Other names: SEROQUEL XR

Primary outcomes

  1. single dose PK parameters(300mg)

    Time frame: Day1 to 48 hour after Day 5

  2. Steady-state multiple doses PK parameters

    Time frame: Day 1 to 48 hours after Day7

Secondary outcomes

  1. Incidence and severity of AEs

    Time frame: sign ICF to Day 9

  2. Clinical significant change in Lab test

    Time frame: baseline up to Day 9

  3. Clinical significant change in vital signs

    Time frame: baseline up to Day 9

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2009
Registry last updated
Mar 26, 2010

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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