Anxiety DisorderPhase 1NCT01256151
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet
A Phase 1 study testing Alprazolam tablet and Alprazolam sublingual in people with Anxiety Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Alprazolam tablet and Alprazolam sublingual
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2011
- 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
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Signed informed consent.
Who cannot join
- Evidence or history of clinically significant abnormalities
- Positive drug screen, excessive alcohol and tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
- Conditions
- Anxiety Disorder
- Being tested
- Alprazolam tablet, Alprazolam sublingual
- Keywords
- Bioequivalence, sublingual, alprazolam, pharmacokinetics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam tabletDrug
1 mg single dose of alprazolam conventional tablet
Alprazolam sublingualDrug
1 mg single dose of alprazolam sublingual tablet
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam conventional tablet | Active comparator | Alprazolam conventional tablet Receives: Drug: Alprazolam tablet |
| Alprazolam sublingual tablet | Experimental | Alprazolam sublingual tablet Receives: Drug: Alprazolam sublingual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) from time zero to last measurable time of alprazolam
Measured: 72 hours
Peak concentration of alprazolam
Measured: 72 hours
Secondary outcomes (7)
Area under the curve from time zero to infinity
Measured: 72 hours
AUC% extrapolated
Measured: 72 hours
Time of Cmax
Measured: 72 hours
half-life of alprazolam
Measured: 72 hours
Clinically significant safety laboratory tests
Measured: Screening, Day 0, Day 4
Clincally significant vital signs
Measured: Screening, Day 4
Clinically significant adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256151
- Sponsor's protocol ID
- A6131024
- Status last verified
- Jan 2021
- First submitted
- 6 Dec 2010
- 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
- Open-label, Randomized, Single-Dose, 2 Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To A Reference Alprazolam Immediate Release Tablet
- ClinicalTrials.gov ID
- NCT01256151
- Acronym / sponsor ID
- A6131024
- Conditions
- Anxiety Disorder
- Keywords
- Bioequivalence, sublingual, alprazolam, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Dec 2010 (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.
To assess if the sublingual tablet will have similar pharmacokinetics as the conventional tablet of alprazolam.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprazolam conventional tablet | Active comparator | Drug: Alprazolam tabletAlprazolam conventional tablet |
| Alprazolam sublingual tablet | Experimental | Drug: Alprazolam sublingualAlprazolam sublingual tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant abnormalities
- Positive drug screen, excessive alcohol and tobacco use
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 tablet1 mg single dose of alprazolam conventional tablet | Drug | Alprazolam conventional tablet |
| Alprazolam sublingual1 mg single dose of alprazolam sublingual tablet | Drug | Alprazolam sublingual tablet |
Primary outcome
Area under the curve (AUC) from time zero to last measurable time of alprazolam
Time frame: 72 hours
Peak concentration of alprazolam
Time frame: 72 hours
7 secondary outcomes
Area under the curve from time zero to infinity
Time frame: 72 hours
AUC% extrapolated
Time frame: 72 hours
Time of Cmax
Time frame: 72 hours
half-life of alprazolam
Time frame: 72 hours
Clinically significant safety laboratory tests
Time frame: Screening, Day 0, Day 4
Clincally significant vital signs
Time frame: Screening, Day 4
Clinically significant adverse events
Time frame: 1 month
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 1 study testing Alprazolam tablet and Alprazolam sublingual in people with Anxiety Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
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 3 inclusion and 2 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 United States. 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 the curve (AUC) from time zero to last measurable time of alprazolam (time frame: 72 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 28 Jan 2021.