HealthyPhase 1NCT01634789
A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
A Phase 1 study testing bazedoxifene and bazedoxifene/conjugated estrogens in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to evaluate 3 test formulations relative to a reference formulation. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- bazedoxifene and bazedoxifene/conjugated estrogens
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2012
- 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 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy postmenopausal women
- Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight >= 50 kg
Who cannot join
- Pregnant or nursing females; females of childbearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Open-label, Single-dose, Randomized, 4-treatment, 4- Period, Crossover, Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene (Bza) Compared With A Reference Tablet Formulation of Bza/Conjugated Estrogens (ce) in Healthy Postmenopausal Women
The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
- Conditions
- Healthy
- Being tested
- bazedoxifene, bazedoxifene/conjugated estrogens
- Keywords
- bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bazedoxifeneDrug
Also called TSE-424
20 mg oral tablet, single dose
bazedoxifeneDrug
Also called TSE-424
20 mg oral tablet, single dose
bazedoxifeneDrug
Also called TSE-424
20 mg oral tablet, single dose
bazedoxifene/conjugated estrogensDrug
Also called BZA/CE
20 mg / 0.625 mg oral tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment 1: bazedoxifene | Experimental | Test Treatment 1 Receives: Drug: bazedoxifene |
| Test Treatment 2: bazedoxifene | Experimental | Test Treatment 2 Receives: Drug: bazedoxifene |
| Test Treatment 3: bazedoxifene | Experimental | Test Treatment 3 Receives: Drug: bazedoxifene |
| Reference Treatment: bazedoxifene/conjugated estrogens | Experimental | Reference Treatment Receives: Drug: bazedoxifene/conjugated estrogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT)
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Secondary outcomes (4)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf)
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Time of Maximum Plasma Concentration (Tmax)
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Elimination-phase Half-life (t1/2)
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Relative Bioavailability (F)
Measured: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: This study was terminated on 10 December 2012 due to low enrollment. The decision to terminate the study was not based on safety or efficacy issues.
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- 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
- NCT01634789
- Sponsor's protocol ID
- B2311014
- Other IDs
- 3115B1-1146
- Status last verified
- Jan 2013
- First submitted
- 3 Jul 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Randomized, 4-treatment, 4- Period, Crossover, Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene (Bza) Compared With A Reference Tablet Formulation of Bza/Conjugated Estrogens (ce) in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01634789
- Acronym / sponsor ID
- B2311014
- Conditions
- Healthy
- Keywords
- bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated on 10 December 2012 due to low enrollment. The decision to terminate the study was not based on safety or efficacy issues.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Jul 2012 (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.
The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Treatment 1: bazedoxifene | Experimental | Drug: bazedoxifeneTest Treatment 1 |
| Test Treatment 2: bazedoxifene | Experimental | Drug: bazedoxifeneTest Treatment 2 |
| Test Treatment 3: bazedoxifene | Experimental | Drug: bazedoxifeneTest Treatment 3 |
| Reference Treatment: bazedoxifene/conjugated estrogens | Experimental | Drug: bazedoxifene/conjugated estrogensReference Treatment |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Generally healthy postmenopausal women
- Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight >= 50 kg
Key exclusion criteria (1 listed)
- Pregnant or nursing females; females of childbearing potential
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 |
|---|---|---|
| bazedoxifeneAlso: TSE-42420 mg oral tablet, single dose | Drug | Test Treatment 1: bazedoxifene |
| bazedoxifeneAlso: TSE-42420 mg oral tablet, single dose | Drug | Test Treatment 2: bazedoxifene |
| bazedoxifeneAlso: TSE-42420 mg oral tablet, single dose | Drug | Test Treatment 3: bazedoxifene |
| bazedoxifene/conjugated estrogensAlso: BZA/CE20 mg / 0.625 mg oral tablet, single dose | Drug | Reference Treatment: bazedoxifene/conjugated estrogens |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Area Under the Concentration-Time Curve from Time 0 to Last Observable Concentration (AUCT)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
4 secondary outcomes
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Time of Maximum Plasma Concentration (Tmax)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Elimination-phase Half-life (t1/2)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Relative Bioavailability (F)
Time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose
Results and safety
The study was stopped early (reason given: This study was terminated on 10 December 2012 due to low enrollment. The decision to terminate the study was not based on safety or efficacy issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- 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 bazedoxifene and bazedoxifene/conjugated estrogens in people with Healthy, run by Pfizer 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Jan 2013. 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 was stopped early (reason given: This study was terminated on 10 December 2012 due to low enrollment. The decision to terminate the study was not based on safety or efficacy issues.). Results are not available in the source record.
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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 9, 16, 24, 48 hours post-dose). 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 18 Jan 2013; AzTrials last refreshed its copy on 31 Oct 2026.