HealthyPhase 4NCT03317236
Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
A Phase 4 study testing Quetiapine in people with Healthy, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
Trial summary
Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteArgentina
- Study dates
- 13 Mar 2017to 1 Oct 2017
- Phase
- Phase 4
- 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
- Signed informed consent.
- Healthy volunteers according to medical history, physical exam, clinical laboratory, chest X-rays and ECG.
- Gender: males and non pregnant females
- Age: 18 to 55 years.
- Body mass index: 19 to 27 kg/m^2.
Who cannot join
- History of liver or renal disease, or psychiatric disorders.
- History of drug or alcohol abuse during the previous two years.
- Smokers of more than 10 cigarrettes a day.
- Any kind of medicines taken during the previous two weeks.
- Any history of disease or disorders clinically significant according to the Principal Investigator.
- Abnormal ECG.
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- Abnormal chest X-ray.
- Hypersensitivity to quetiapine or excipients within the formulations.
- Positive diagnostic test for HIV or hepatitis A, B or C virus.
- Breast feeding females.
- Positive beta-HCG test.
- Positive drug test in urine.
- Participation in clinical trials in the previous three months.
- Blood donation in the previous three months.
- Clinically significant laboratory results.
- Subjects seeking to initiate any medical or pharmacological treatment.
- Subjects unwilling to keep fasting or diet indications.
- Uncooperative subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A.
Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.
- Conditions
- Healthy
- Being tested
- Quetiapine
- Keywords
- Bioequivalence, Quetiapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
A fixed 50 mg exteded release formulation.
| Study group | Role | What they receive |
|---|---|---|
| Reference - Test | Experimental | A new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R). Receives: Drug: Quetiapine |
| Test - Reference | Experimental | A branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T). Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 36 hours
AUC
Area under curve
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start13 Mar 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-dose, two-way crossover.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorio Elea Phoenix S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DominguezLab S.R.L.
- Responsible party
- Sponsor
- Investigators
- María C Fritz, MD, Principal investigator, DominguezLab S.R.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317236
- Sponsor's protocol ID
- PRO-BEQ-QTP-002-V.01
- Status last verified
- Oct 2017
- First submitted
- 18 Oct 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A.
- ClinicalTrials.gov ID
- NCT03317236
- Acronym / sponsor ID
- PRO-BEQ-QTP-002-V.01
- Conditions
- Healthy
- Keywords
- Bioequivalence, Quetiapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Laboratorio Elea Phoenix S.A.Industry (pharma, biotech, devices)
- Collaborators
- DominguezLab S.R.L.
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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.
Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way crossover design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-dose, two-way crossover.
| Arm | Type | Receives |
|---|---|---|
| Reference - Test | Experimental | Drug: QuetiapineA new extended release formulation containing quetiapine 50 mg (T) followed by a branded formulation (R). |
| Test - Reference | Experimental | Drug: QuetiapineA branded formulation (R) followed by a new extended release formulation containing quetiapine 50 mg (T). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Healthy volunteers according to medical history, physical exam, clinical laboratory, chest X-rays and ECG.
- Gender: males and non pregnant females
- Age: 18 to 55 years.
- Body mass index: 19 to 27 kg/m^2.
Key exclusion criteria (18 listed)
- History of liver or renal disease, or psychiatric disorders.
- History of drug or alcohol abuse during the previous two years.
- Smokers of more than 10 cigarrettes a day.
- Any kind of medicines taken during the previous two weeks.
- Any history of disease or disorders clinically significant according to 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 |
|---|---|---|
| QuetiapineA fixed 50 mg exteded release formulation. | Drug | Reference - Test, Test - Reference |
Primary outcome
Cmax
Time frame: 36 hours
Maximum plasma concentration
AUC
Time frame: 36 hours
Area under curve
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 23 Oct 2017.
- Individual participant dataSharing planned: No
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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.
María C Fritz, MD principal investigator
DominguezLab S.R.L.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine in people with Healthy, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.
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 5 inclusion and 18 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 23 Oct 2017. 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 Argentina. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cmax (time frame: 36 hours). 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 23 Oct 2017.