HealthyPhase 1NCT01285505
Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
A Phase 1 study testing alprazolam commercial sublingual formulation and alprazolam test sublingual tablet in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation. 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 commercial sublingual formulation and alprazolam test sublingual tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jun 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 or female subjects
- BMI 18 to 26.9
- must give informed consent
Who cannot join
- clinically significant disease
- narrow angle glaucoma
- positive drug screen
About this study
Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
- Conditions
- Healthy
- Being tested
- alprazolam commercial sublingual formulation, alprazolam test sublingual tablet
- Keywords
- alprazolam, sublingual, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alprazolam commercial sublingual formulationDrug
0.5 mg tablet, single dose
alprazolam test sublingual tabletDrug
0.5 mg tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam commercial sublingual tablet | Active comparator | Not described Receives: Drug: alprazolam commercial sublingual formulation |
| Alprazolam test sublingual tablet | Experimental | Not described Receives: Drug: alprazolam test sublingual tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)
Measured: 11 days
Alprazolam bioavailability as assessed by peak concentration (Cmax)
Measured: 11 days
Secondary outcomes (5)
Alprazolam time of maximum concentration (Tmax)
Measured: 11 days
Half life of alprazolam
Measured: 11 days
Clinically significant safety laboratory tests
Measured: 11 days
Clinically significant adverse events
Measured: 11 days
Clinically significant 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 posted28 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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
- 0 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
- NCT01285505
- Sponsor's protocol ID
- A6131020
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 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
- Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
- ClinicalTrials.gov ID
- NCT01285505
- Acronym / sponsor ID
- A6131020
- Conditions
- Healthy
- Keywords
- alprazolam, sublingual, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 28 Jan 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.
This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprazolam commercial sublingual tablet | Active comparator | Drug: alprazolam commercial sublingual formulation |
| Alprazolam test sublingual tablet | Experimental | Drug: alprazolam test 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 or female subjects
- BMI 18 to 26.9
- must give 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 commercial sublingual formulation0.5 mg tablet, single dose | Drug | Alprazolam commercial sublingual tablet |
| alprazolam test sublingual tablet0.5 mg tablet, single dose | Drug | Alprazolam test sublingual tablet |
Primary outcome
Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)
Time frame: 11 days
Alprazolam bioavailability as assessed by peak concentration (Cmax)
Time frame: 11 days
5 secondary outcomes
Alprazolam time of maximum concentration (Tmax)
Time frame: 11 days
Half life of alprazolam
Time frame: 11 days
Clinically significant safety laboratory tests
Time frame: 11 days
Clinically significant adverse events
Time frame: 11 days
Clinically significant vital signs
Time frame: 11 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alprazolam commercial sublingual formulation and alprazolam test sublingual tablet in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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 as assessed from the area under the concentration-time curve (AUC) (time frame: 11 days). 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.