HealthyPhase 1NCT00860119
Bioequivalence of Alprazolam Sublingual vs Oral Tablets
A Phase 1 study testing alprazolam sublingual tablet and alprazolam oral tablet in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in India.
Trial summary
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- alprazolam sublingual tablet and alprazolam oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2009to Oct 2009
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- BMI 17.5 - 30.5
- Must provide informed consent
Who cannot join
- Clinically significant disease
- Narrow angle glaucoma
- Positive drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.
- Conditions
- Healthy
- Being tested
- alprazolam sublingual tablet, alprazolam oral tablet
- Keywords
- Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alprazolam sublingual tabletDrug
1 mg alprazolam sublingual tablet, given as a single dose to each subject
alprazolam oral tabletDrug
Also called Xanax
1 mg alprazolam immediate release oral tablet, given as a single dose to each subject
| Study group | Role | What they receive |
|---|---|---|
| Sublingual tablet | Experimental | Test treatment Receives: Drug: alprazolam sublingual tablet |
| Oral tablet | Experimental | Reference treatment Receives: Drug: alprazolam oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
Measured: 11 days
Secondary outcomes (2)
Alprazolam time of maximum concentration (Tmax) and half life
Measured: 11 days
Adverse events, clinical laboratory tests, vital signs
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT00860119
- Sponsor's protocol ID
- A6131017
- Status last verified
- Jan 2021
- First submitted
- 10 Mar 2009
- 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 Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)
- ClinicalTrials.gov ID
- NCT00860119
- Acronym / sponsor ID
- A6131017
- Conditions
- Healthy
- Keywords
- Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Mar 2009 (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 study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual tablet | Experimental | Drug: alprazolam sublingual tabletTest treatment |
| Oral tablet | Experimental | Drug: alprazolam oral tabletReference treatment |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects
- BMI 17.5 - 30.5
- Must provide informed consent
Key exclusion criteria (3 listed)
- Clinically significant disease
- Narrow angle glaucoma
- Positive drug screen
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 sublingual tablet1 mg alprazolam sublingual tablet, given as a single dose to each subject | Drug | Sublingual tablet |
| alprazolam oral tabletAlso: Xanax1 mg alprazolam immediate release oral tablet, given as a single dose to each subject | Drug | Oral tablet |
Primary outcome
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
Time frame: 11 days
2 secondary outcomes
Alprazolam time of maximum concentration (Tmax) and half life
Time frame: 11 days
Adverse events, clinical laboratory tests, vital signs
Time frame: 11 days
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 sublingual tablet and alprazolam oral tablet in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 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 3 inclusion and 3 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 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?
Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax) (time frame: 11 days). 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.