SchizophreniaPhase 1NCT00919607
Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients
A Phase 1 study testing quetiapine fumarate extended-release in people with Schizophrenia, run by AstraZeneca at 1 site in China.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- quetiapine fumarate extended-release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- AIDS \& hepatitis B
- History of seizure disorder
- History of episodic,idiopathic orthostatic hypotension
Trial locations and contacts
1 site in 1 country.
About this study
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 .
- Conditions
- Schizophrenia
- Being tested
- quetiapine fumarate extended-release
- Keywords
- quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study, pharmacokinetics parameters
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapine fumarate extended-releaseDrug
Also called SEROQUEL XR
200mg,oral,single dose
quetiapine fumarate extended-releaseDrug
Also called SEROQUEL XR
300mg,oral,single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | quetiapine fumarate extended-release 300mg,administered once-daily Day1~5 Receives: Drug: quetiapine fumarate extended-release |
| 2 | Experimental | quetiapine fumarate extended-release 300mg/Day1,600mg/Day2~6,administered once-daily Receives: Drug: quetiapine fumarate extended-release |
| 3 | Experimental | quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3~7,administered once-daily Receives: Drug: quetiapine fumarate extended-release |
What is being measured
The primary outcome is the main question the study is designed to answer.
single dose PK parameters(300mg)
Measured: Day1 to 48 hour after Day 5
Steady-state multiple doses PK parameters
Measured: Day 1 to 48 hours after Day7
Secondary outcomes (3)
Incidence and severity of AEs
Measured: sign ICF to Day 9
Clinical significant change in Lab test
Measured: baseline up to Day 9
Clinical significant change in vital signs
Measured: baseline up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tianmei Si, Principal investigator, Peking University Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919607
- Sponsor's protocol ID
- D1444C00007
- Status last verified
- Mar 2010
- First submitted
- 11 Jun 2009
- Last updated
- 26 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00919607
- Acronym / sponsor ID
- D1444C00007
- Conditions
- Schizophrenia
- Keywords
- quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study, pharmacokinetics parameters
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: quetiapine fumarate extended-releasequetiapine fumarate extended-release 300mg,administered once-daily Day1~5 |
| 2 | Experimental | Drug: quetiapine fumarate extended-releasequetiapine fumarate extended-release 300mg/Day1,600mg/Day2~6,administered once-daily |
| 3 | Experimental | Drug: quetiapine fumarate extended-releasequetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3~7,administered once-daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- AIDS \& hepatitis B
- History of seizure disorder
- History of episodic,idiopathic orthostatic hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quetiapine fumarate extended-releaseAlso: SEROQUEL XR200mg,oral,single dose | Drug | 3 |
| quetiapine fumarate extended-releaseAlso: SEROQUEL XR300mg,oral,single dose | Drug | 1, 2, 3 |
Primary outcome
single dose PK parameters(300mg)
Time frame: Day1 to 48 hour after Day 5
Steady-state multiple doses PK parameters
Time frame: Day 1 to 48 hours after Day7
3 secondary outcomes
Incidence and severity of AEs
Time frame: sign ICF to Day 9
Clinical significant change in Lab test
Time frame: baseline up to Day 9
Clinical significant change in vital signs
Time frame: baseline up to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianmei Si principal investigator
Peking University Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quetiapine fumarate extended-release in people with Schizophrenia, run by AstraZeneca at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single dose PK parameters(300mg) (time frame: Day1 to 48 hour after Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2010.