HealthyPhase 1NCT01566487
Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition
A Phase 1 study testing Quetiapine fumarate in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quetiapine fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent for participation in the study by the patient and Patient's Legally Acceptable Representative (LAR). If the patient or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.
- Schizophrenic patients, between 18 and 55 years of age (inclusive).
- Patient has a documented clinical diagnosis of stable schizophrenia (DSM IV-TR) controlled by a stable 300 mg Quetiapine regimen given at 12-hour intervals from at least 2 weeks prior to the first dosing, as confirmed by Principal Investigator
- Having a Body Mass Index (BMI) between 18 and 35 (inclusive). calculated as weight in kg/height in m2.
- Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG recordings and Chest X ray (Postero-anterior view).
- The investigator must ensure that the respective hepatic, renal, haematopoietic, cardiac and respiratory functions are appropriate to include the patient in the study.
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- Able to comply with study procedures in the opinion of the investigator.
- In case of female patient the serum pregnancy test at screening visit must be negative.
- Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide. diaphragm with spermicide.Absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration,during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. (It is investigator's responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient/LAR in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol).
- In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
- (It is investigator's responsibility to ensure that above points regarding an effective method of avoiding pregnancy are discussed with patient/LAR in detail and patient agreed for this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol).
Who cannot join
- Known hypersensitivity/allergy or idiosyncratic reaction to Quetiapine or its excipients.
- Clinically significant illnesses (including hypotensive episodes and systemic infection) or surgery within 4 weeks prior to the first dosing.
- Current or relevant history of serious. severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) AXIS I) except schizophrenia.
- History of syncope or orthostatic hypotension
- Ingestion of any medication other than listed below at any time in 10 days before the first study drug administration. In any such case Patient selection will be at the discretion of the Principal Investigator.
- Following is the list of permissible medications, provided, the patients are on a stable regimen at least I0 days prior to and throughout the study.
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- Alprazolam, Fluoxetin, Imipramine, Haloperidol, Risperidone. (Refer Appendix 4 for list of nonpermissible medication)
- A history of alcohol or drug dependence by DSM-IV criteria within 6 months prior to screening.
- Smokers who smoke 10 or more than 10 cigarette/day or inability to abstain from smoking during the study
- Donation of blood (≥ 1 unit or 350 mL) within 90 days prior to receiving the first dose of study medication or during the study.
- Note: In case the blood loss is less than or equol to 200 mL; patient may be dosed 60 days after blood donation.
- A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
- Positive test for HIV infection.
- ECG abnormalities (clinically relevant), vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mnHg, diastolic blood pressure lower than 50 or over 90 mmHg or patient on any antihypertensive medication or heart rate less than 50 or over 100 bpm) or significant orthostatic hypotension (i.e.. a drop in systolic blood pressure of 30 mmHg or more and/or a drop in diastolic blood pressure of 20 mmHg or more on standing) at screening. Patients with vital signs values no more than 5% out of the specified range but considered stable could be included in the study at the discretion of the investigator.
- Any condition1 Abnormal baseline findings that in the investigator's judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
- The receipt of an investigational product or participation in a drug research study within a period of 30 days prior to the first dose of study medication.
- Note: Elimination half-life of the study drug should be taken into consideration for inclusion of the Patient in the study.
- Psychosis judged to be the direct physiological effect of an abused medication or substance.
- Positive testing for the drugs of abuse (amphetamines, barbiturates ,benzodiazepines, cocaine, morphine, marijuana) done by urine scan at Screening. (Except for alprazolam which is a permissible medication).
- Known history of Organic Brain Disorder.
- Hospitalisation for an exacerbation of schizophrenia within two months prior to screening and during the screening period.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Patients with the following cardiac conditions are excluded:
- Recent myocardial infarction (<I2 months)
- QTc prolongation (screening electrocardiogram with QTc > 450 msec for men, QTc > 470 msec for women)
- History of QTc prolongation or using concomitant medications which prolong QTc interval
- Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia
- Uncompensated congestive heart failure
- Complete left bundle branch block
- First-degree heart block with PR interval > 0.22 seconds
- Presence of cataract on Ophthalmoscopic examination (slit lamp exam).
- History of agranulocytosis.
- Known case of Diabetes mellitus or fasting blood glucose ≥126 mg/dl at screening visit.
- Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease (e.g, hepatic insufficiency), or other conditions known to interfere with the absorption, distribution,metabolism, or excretion of the drug.
- Concurrent Parkinson's disease
- Clinically significant history of cataracts, tardive dyskinesia. neuroleptics malignant syndrome. epilepsy or seizure.
- Any clinically relevant neurological, endocrinal. cardiovascular. cerebrovascular, pulmonary, hematological, or immunologic disease could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial
- Any reason that, in the opinion of the Investigator, would prevent the patient from participating in the study.
- Patients with abnormal thyroid function test at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could Interfere with the conduct of the trial.
- Patient with hyperprolactinemia at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- Dementia related psychosis.
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-Label, Balanced, Two-treatment, Two-period, Two-sequence, Crossover, Multicentric Experimental Bioequivalence Study of Quetiapine Fumarate Film-coated Tablets 300 mg (Test)and Seroquel Film-coated Tablets 300 mg (Reference) Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.
Read the detailed description
The objective of this study was to compare the bioavailability and characterise the pharmacokinetics profile of the sponsor formulation Quetiapine fumarate tablets 300 mg of Dr. Reddy's Laboratories Limited, India with respect to reference formulation Seroquel tablets 300 mg of Astrazeneca Pharmaceuticals, USA in adults schizophrenia patients under fasting condition.
54 subjects were dosed and were enrolled in the study.
- Conditions
- Healthy
- Being tested
- Quetiapine fumarate
- Keywords
- Bioequivalence, Quetiapine fumarate, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
Also called Seroquel
Quetiapine fumarate tablets 300mg
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine fumarate tablets 300 mg | Experimental | Quetiapine fumarate film-coated tablets 300 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Quetiapine fumarate |
| Seroquel | Active comparator | Seroquel film-coated tablets 300 mg of Astrazeneca Pharmaceuticals, USA Receives: Drug: Quetiapine fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve(AUC)
Measured: Period 1 - Pre-dose in day 3, 4 and 5 and period 2 pre dose in day8,9 and 10 and 0.25,0.5,0.75,1.25,1.5,1.75,2,2.5,3,4,6,8,10 & 12 hrs post-dose on day 5 and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr.Sachin Patkar, MD, Principal investigator, Masina hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566487
- Sponsor's protocol ID
- 353-09
- Status last verified
- Apr 2010
- First submitted
- 28 Mar 2012
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Balanced, Two-treatment, Two-period, Two-sequence, Crossover, Multicentric Experimental Bioequivalence Study of Quetiapine Fumarate Film-coated Tablets 300 mg (Test)and Seroquel Film-coated Tablets 300 mg (Reference) Under Fasting Condition
- ClinicalTrials.gov ID
- NCT01566487
- Acronym / sponsor ID
- 353-09
- Conditions
- Healthy
- Keywords
- Bioequivalence, Quetiapine fumarate, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Mar 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.
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.
Detailed description
The objective of this study was to compare the bioavailability and characterise the pharmacokinetics profile of the sponsor formulation Quetiapine fumarate tablets 300 mg of Dr. Reddy's Laboratories Limited, India with respect to reference formulation Seroquel tablets 300 mg of Astrazeneca Pharmaceuticals, USA in adults schizophrenia patients under fasting condition.
54 subjects were dosed and were enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine fumarate tablets 300 mg | Experimental | Drug: Quetiapine fumarateQuetiapine fumarate film-coated tablets 300 mg of Dr. Reddy's Laboratories Limited |
| Seroquel | Active comparator | Drug: Quetiapine fumarateSeroquel film-coated tablets 300 mg of Astrazeneca Pharmaceuticals, USA |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Written informed consent for participation in the study by the patient and Patient's Legally Acceptable Representative (LAR). If the patient or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.
- Schizophrenic patients, between 18 and 55 years of age (inclusive).
- Patient has a documented clinical diagnosis of stable schizophrenia (DSM IV-TR) controlled by a stable 300 mg Quetiapine regimen given at 12-hour intervals from at least 2 weeks prior to the first dosing, as confirmed by Principal Investigator
- Having a Body Mass Index (BMI) between 18 and 35 (inclusive). calculated as weight in kg/height in m2.
- Not having any significant diseases or clinically significant abnormal findings except schizophrenia during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG recordings and Chest X ray (Postero-anterior view).
Key exclusion criteria (42 listed)
- Known hypersensitivity/allergy or idiosyncratic reaction to Quetiapine or its excipients.
- Clinically significant illnesses (including hypotensive episodes and systemic infection) or surgery within 4 weeks prior to the first dosing.
- Current or relevant history of serious. severe or unstable psychiatric illness (Meeting the criteria for any other (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) AXIS I) except schizophrenia.
- History of syncope or orthostatic hypotension
- Ingestion of any medication other than listed below at any time in 10 days before the first study drug administration. In any such case Patient selection will be at the discretion of the Principal Investigator.
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 fumarateAlso: SeroquelQuetiapine fumarate tablets 300mg | Drug | Quetiapine fumarate tablets 300 mg, Seroquel |
Primary outcome
Area under curve(AUC)
Time frame: Period 1 - Pre-dose in day 3, 4 and 5 and period 2 pre dose in day8,9 and 10 and 0.25,0.5,0.75,1.25,1.5,1.75,2,2.5,3,4,6,8,10 & 12 hrs post-dose on day 5 and day 10
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 29 Mar 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.
Dr.Sachin Patkar, MD principal investigator
Masina hospital
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 in people with Healthy, run by Dr. Reddy's Laboratories 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 11 inclusion and 42 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 29 Mar 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.
What does the primary outcome measure?
Area under curve(AUC) (time frame: Period 1 - Pre-dose in day 3, 4 and 5 and period 2 pre dose in day8,9 and 10 and 0.25,0.5,0.75,1.25,1.5,1.75,2,2.5,3,4,6,8,10 & 12 hrs post-dose on day 5 and day 10). 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 29 Mar 2012.