Healthy SubjectsPhase 1NCT01330472
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
A Phase 1 study testing Xanax XR tablets 3 mg (sourced from Caugus) and Xanax XR tablets 3 mg (sourced from Barceloneta) in people with Healthy Subjects, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
Trial summary
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Xanax XR tablets 3 mg (sourced from Caugus) and Xanax XR tablets 3 mg (sourced from Barceloneta)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- May 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 20 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 20 and 55 years, inclusive.
- An informed consent document signed and dated by the subject.
Who cannot join
- Evidence or history of clinically significant abnormality.
- A positive urine drug screen.
- Subjects who are hypersensitive to alprazolam or related compounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
- Conditions
- Healthy Subjects
- Being tested
- Xanax XR tablets 3 mg (sourced from Caugus), Xanax XR tablets 3 mg (sourced from Barceloneta)
- Keywords
- Alprazolam, Xanax, Bioequivalence, Panic disorder with or without agoraphobia.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanax XR tablets 3 mg (sourced from Caugus)Drug
Tablets, 3 mg, single dose
Xanax XR tablets 3 mg (sourced from Barceloneta)Drug
Tablets, 3 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| Xanax XR tablets 3 mg (sourced from Caugus) | Active comparator | Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE) Receives: Drug: Xanax XR tablets 3 mg (sourced from Caugus) |
| Xanax XR tablets 3 mg (sourced from Barceloneta), | Experimental | Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST) Receives: Drug: Xanax XR tablets 3 mg (sourced from Barceloneta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to infinity (AUCinf) of alprazolam
Measured: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Peak plasma conc (Cmax) of alprazolam
Measured: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Secondary outcomes (4)
Area under the curve from zero to the last time point (AUClast) of alprazolam
Measured: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Area under the curve extrapolated (AUC%extrap) of alprazolam
Measured: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Terminal half life of alprazolam
Measured: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Time to peak concentration (Tmax) of alprazolam
Measured: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 16 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
- NCT01330472
- Sponsor's protocol ID
- A6131025
- Status last verified
- Jan 2021
- First submitted
- 5 Apr 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
- An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Xanax XR Tablet 3 mg (Sourced From Caguas) Versus Xanax XR Tablet 3 mg (Sourced From Barceloneta) In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01330472
- Acronym / sponsor ID
- A6131025
- Conditions
- Healthy Subjects
- Keywords
- Alprazolam, Xanax, Bioequivalence, Panic disorder with or without agoraphobia.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 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
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Apr 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.
Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xanax XR tablets 3 mg (sourced from Caugus) | Active comparator | Drug: Xanax XR tablets 3 mg (sourced from Caugus)Xanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE) |
| Xanax XR tablets 3 mg (sourced from Barceloneta), | Experimental | Drug: Xanax XR tablets 3 mg (sourced from Barceloneta)Xanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST) |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive.
- An informed consent document signed and dated by the subject.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant abnormality.
- A positive urine drug screen.
- Subjects who are hypersensitive to alprazolam or related compounds.
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 |
|---|---|---|
| Xanax XR tablets 3 mg (sourced from Caugus)Tablets, 3 mg, single dose | Drug | Xanax XR tablets 3 mg (sourced from Caugus) |
| Xanax XR tablets 3 mg (sourced from Barceloneta)Tablets, 3 mg, single dose | Drug | Xanax XR tablets 3 mg (sourced from Barceloneta), |
Primary outcome
Area under the curve from time zero to infinity (AUCinf) of alprazolam
Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Peak plasma conc (Cmax) of alprazolam
Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
4 secondary outcomes
Area under the curve from zero to the last time point (AUClast) of alprazolam
Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Area under the curve extrapolated (AUC%extrap) of alprazolam
Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Terminal half life of alprazolam
Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Time to peak concentration (Tmax) of alprazolam
Time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
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 Xanax XR tablets 3 mg (sourced from Caugus) and Xanax XR tablets 3 mg (sourced from Barceloneta) in people with Healthy Subjects, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
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 2 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 Singapore. 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 from time zero to infinity (AUCinf) of alprazolam (time frame: Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose). 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.