SchizophreniaPhase 1NCT01634373
Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets
A Phase 1 study testing Torrent's Quetiapine Fumarate Tablets in people with Schizophrenia, run by Torrent Pharmaceuticals Limited at 1 site in India.
Trial summary
Objective: Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate Tablets 300 mg. Study Design: Randomized, Two-Way, Crossover, multiple Dose, and Open-Label Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Torrent's Quetiapine Fumarate Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteIndia
- Study dates
- Start not givento not given
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: Male of female
- Age: 25-65 years
- Patients who are receiving a stable daily dose of quetiapine 300 mg every 12 hourly for atlist one month
- Patient willing to adhere to the protocol requirements
Who cannot join
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG.
- Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
- Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
- History of allergic reactions to quetiapine or other chemically related psychotropic drugs.
- Concurrent primary psychiatric or neurological diagnosis including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease.
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- Existence of any surgical or medical condition, which in the judgement of the Principal Investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of patients.
- Concurrent use of other drugs known to suppress bone marrow function.
- HIV, HCV, HBsAg positive.
- Expected changes in concomitant medications during the period of study.
- A history of epilepsy or risk for seizures
- positive urine drug of abuse test at enrollment.
- A history of alcohol or drug dependence by Diagnostic and statistical manual of Mental disorders IV(DSM-IV) criteria during the 6 month period immediately prior to study entry.
- A total white blood cell count below 4000/ml, or absolute neutrophil count below 2000/ml
- Female patients with pregnancy or Breast feeding or intend to become pregnant during the study and not able to follow contraception methods.
- History of multiple syncopal episodes.
- Administration any study drugs in last 3 months prior to entry in the study.
- History of significant blood loss due to any reason in the past 3 months.
- Any pre-existing bleeding disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Steady State Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 300 mg Tablet [Reference Formulation; AstraZeneca, USA] in Schizophrenic Patients.
Objective:
Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate Tablets 300 mg.
Study Design:
Randomized, Two-Way, Crossover, multiple Dose, and Open-Label
- Conditions
- Schizophrenia
- Being tested
- Torrent's Quetiapine Fumarate Tablets
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torrent's Quetiapine Fumarate TabletsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
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.
- 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
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634373
- Sponsor's protocol ID
- PK-08-111
- Status last verified
- Jul 2012
- First submitted
- 27 Jun 2012
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Steady State Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 300 mg Tablet [Reference Formulation; AstraZeneca, USA] in Schizophrenic Patients.
- ClinicalTrials.gov ID
- NCT01634373
- Acronym / sponsor ID
- PK-08-111
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 6 Jul 2012 (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.
Objective:
Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate Tablets 300 mg.
Study Design:
Randomized, Two-Way, Crossover, multiple Dose, and Open-Label
Study design
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sex: Male of female
- Age: 25-65 years
- Patients who are receiving a stable daily dose of quetiapine 300 mg every 12 hourly for atlist one month
- Patient willing to adhere to the protocol requirements
Key exclusion criteria (19 listed)
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- Clinically significant abnormal ECG.
- Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
- Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
- History of allergic reactions to quetiapine or other chemically related psychotropic drugs.
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 |
|---|---|---|
| Torrent's Quetiapine Fumarate Tablets | Drug | – |
Primary outcome
Not reported in the source record.
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 6 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Torrent's Quetiapine Fumarate Tablets in people with Schizophrenia, run by Torrent Pharmaceuticals Limited at 1 site in India.
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 19 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 6 Jul 2012. 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 India. 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.
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 6 Jul 2012.