HealthyPhase 4NCT01322867
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
A Phase 4 study testing alprazolam tablet and alprazolam oral solution in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Brazil.
Trial summary
A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers. 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?
- alprazolam tablet and alprazolam oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Sep 2011
- 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
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
- The BMI - Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 15% due to the upper limit (18,5 to 28,63) and total body weight >50kg
- An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- A history of suicidal thoughts, behavior or suicide attempts
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Known hypersensitivity to alprazolam or any components of the product
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- A positive bHCG exam for women
- Subjects with myasthenia gravis or acute narrow angle glaucoma
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ICF - Instituto de Ciencias Farmaceuticas
Aparecida de Goiânia, Goiás, 74935-530
About this study
Official title: A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.
A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.
- Conditions
- Healthy
- Being tested
- alprazolam tablet, alprazolam oral solution
- Keywords
- bioequivalence study, alprazolam, frontal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alprazolam tabletDrug
0,25 mg oral tablets given once
alprazolam oral solutionDrug
0,75 mg/ml Oral Solution (Drops) given once
| Study group | Role | What they receive |
|---|---|---|
| Reference Drug | Active comparator | Not described Receives: Drug: alprazolam tablet |
| Test Drug | Active comparator | Not described Receives: Drug: alprazolam oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug
Measured: Up to 72h
Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast))
Measured: Up to 72h
Secondary outcomes (5)
Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf))
Measured: Up to 72h
Time to peak concentration of Test Drug and Reference Drug (Tmax)
Measured: Up to 72h
Half-life of Test Drug and Reference Drug (T1/2)
Measured: Up to 72h
Elimination rate constant (K el)
Measured: Up to 72h
Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity
Measured: Up to 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322867
- Sponsor's protocol ID
- A6131023
- Status last verified
- Jan 2021
- First submitted
- 23 Mar 2011
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01322867
- Acronym / sponsor ID
- A6131023
- Conditions
- Healthy
- Keywords
- bioequivalence study, alprazolam, frontal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Mar 2011 (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.
A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form, Under Fasted Conditions in Healthy Volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Drug | Active comparator | Drug: alprazolam tablet |
| Test Drug | Active comparator | Drug: alprazolam oral solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
- The BMI - Body Mass Index of the volunteers should be within the range of 18,5 to 24,9 (Dietary Guidelines for Americans) and it may vary up to 15% due to the upper limit (18,5 to 28,63) and total body weight >50kg
- An informed consent document signed and dated by the subject or a legally acceptable representative. If the subject and/or legally acceptable representative cannot read, then the informed consent document may be signed by an impartial witness
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria (7 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- A history of suicidal thoughts, behavior or suicide attempts
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Known hypersensitivity to alprazolam or any components of the product
- History of sensitivity to heparin or heparin-induced thrombocytopenia
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 |
|---|---|---|
| alprazolam tablet0,25 mg oral tablets given once | Drug | Reference Drug |
| alprazolam oral solution0,75 mg/ml Oral Solution (Drops) given once | Drug | Test Drug |
Primary outcome
Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug
Time frame: Up to 72h
Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast))
Time frame: Up to 72h
5 secondary outcomes
Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf))
Time frame: Up to 72h
Time to peak concentration of Test Drug and Reference Drug (Tmax)
Time frame: Up to 72h
Half-life of Test Drug and Reference Drug (T1/2)
Time frame: Up to 72h
Elimination rate constant (K el)
Time frame: Up to 72h
Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity
Time frame: Up to 72h
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 28 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 alprazolam tablet and alprazolam oral solution in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Brazil.
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 7 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 28 Jan 2021. 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 Brazil. 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?
Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug (time frame: Up to 72h). 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 28 Jan 2021.