Urinary Bladder, OveractivePhase 1NCT01521767
Pharmacokinetics and Relative Bioavailability Study
A Phase 1 study testing tolterodine tartrate in people with Urinary Bladder, Overactive, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Singapore.
Trial summary
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- tolterodine tartrate
- 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
- Oct 2011to Nov 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 21 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 21 and 55 years, inclusive
Who cannot join
- Evidence or history of clinically significant diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Read the detailed description
Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
- Conditions
- Urinary Bladder, Overactive
- Being tested
- tolterodine tartrate
- Keywords
- pharmacokinetics, relative bioavailability, tolterodine microspheres in powder blend, Overactive Urinary Bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolterodine tartrateDrug
4 mg single dose of extended release capsules
tolterodine tartrateDrug
4 mg single dose of microspheres in powder blend
tolterodine tartrateDrug
4 mg single dose of microspheres in powder blend
tolterodine tartrateDrug
4 mg single dose of microspheres in powder blend
tolterodine tartrateDrug
4 mg single dose of microspheres in powder blend
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 4 mg tolterodine extended release capsules, administered with water and under fasting condition. Receives: Drug: tolterodine tartrate |
| B | Experimental | 4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition. Receives: Drug: tolterodine tartrate |
| C | Experimental | 4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition. Receives: Drug: tolterodine tartrate |
| D | Experimental | 4 mg MPB-RR1, administered without water and under fed condition. Receives: Drug: tolterodine tartrate |
| E | Experimental | 4 mg MPB-RR1, administered with water and under fasting condition. Receives: Drug: tolterodine tartrate |
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 Last Quantifiable Concentration (AUClast) of tolterodine
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of tolterodine
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Secondary outcomes (8)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of 5-HMT
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Plasma Decay Half-Life (t1/2) of tolterodine
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Plasma Decay Half-Life (t1/2) of 5-HMT
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 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 posted31 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Other
- 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
- NCT01521767
- Sponsor's protocol ID
- A6121196
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2012
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
- ClinicalTrials.gov ID
- NCT01521767
- Acronym / sponsor ID
- A6121196
- Conditions
- Urinary Bladder, Overactive
- Keywords
- pharmacokinetics, relative bioavailability, tolterodine microspheres in powder blend, Overactive Urinary Bladder
- 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
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Jan 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.
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Detailed description
Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: tolterodine tartrate4 mg tolterodine extended release capsules, administered with water and under fasting condition. |
| B | Experimental | Drug: tolterodine tartrate4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition. |
| C | Experimental | Drug: tolterodine tartrate4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition. |
| D | Experimental | Drug: tolterodine tartrate4 mg MPB-RR1, administered without water and under fed condition. |
| E | Experimental | Drug: tolterodine tartrate4 mg MPB-RR1, administered with water and under fasting condition. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant diseases
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 |
|---|---|---|
| tolterodine tartrate4 mg single dose of extended release capsules | Drug | A |
| tolterodine tartrate4 mg single dose of microspheres in powder blend | Drug | B |
| tolterodine tartrate4 mg single dose of microspheres in powder blend | Drug | C |
| tolterodine tartrate4 mg single dose of microspheres in powder blend | Drug | D |
| tolterodine tartrate4 mg single dose of microspheres in powder blend | Drug | E |
Primary outcome
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of tolterodine
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
8 secondary outcomes
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine.
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of 5-HMT
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Plasma Decay Half-Life (t1/2) of tolterodine
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
Plasma Decay Half-Life (t1/2) of 5-HMT
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose
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 27 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 tolterodine tartrate in people with Urinary Bladder, Overactive, 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 1 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: finished, as of the sponsor's last update on 27 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 Last Quantifiable Concentration (AUClast) of tolterodine (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 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 27 Jan 2021.