Urinary Bladder, Overactive Clinical Trial
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
| NCT number | NCT01521767 |
| Other study ID # | A6121196 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | October 2011 |
| Est. completion date | November 2011 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive Exclusion Criteria: - Evidence or history of clinically significant diseases |
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Pfizer Investigational Site | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Primary | Maximum Observed Plasma Concentration (Cmax) of tolterodine | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of tolterodine. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of 5-HMT | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of 5-HMT | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Plasma Decay Half-Life (t1/2) of tolterodine | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | ||
| Secondary | Plasma Decay Half-Life (t1/2) of 5-HMT | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
| Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
| Recruiting |
NCT04807920 -
BOTOX® at the Time of Prolapse Surgery for OAB
|
Phase 4 | |
| Terminated |
NCT02385500 -
Fesoterodine on Urgency Episodes in Parkinson's Disease Population
|
Phase 4 | |
| Not yet recruiting |
NCT02477241 -
Brain Areas Involved in Bladder Filling and Contraction
|
N/A | |
| Completed |
NCT01698138 -
Prevention of Bladder Dysfunction in Acute Spinal Cord Injury
|
Phase 4 | |
| Completed |
NCT00613327 -
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
|
Phase 4 | |
| Completed |
NCT00527033 -
A Study of YM178 in Patients With Symptomatic Overactive Bladder
|
Phase 2 | |
| Completed |
NCT00368706 -
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
|
Phase 3 | |
| Recruiting |
NCT04305743 -
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
|
Phase 4 | |
| Active, not recruiting |
NCT03681678 -
Laser Therapy for Treatment of Urogenital Symptoms in Women
|
||
| Completed |
NCT01655069 -
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
|
Phase 3 | |
| Completed |
NCT01558856 -
Unilateral Versus Bilateral Neuromodulation Tests in the Treatment of Refractory Idiopathic Overactive Bladder
|
N/A | |
| Completed |
NCT01194999 -
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
|
Phase 4 | |
| Completed |
NCT01157377 -
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
|
Phase 2 | |
| Completed |
NCT01381120 -
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
|
Phase 4 | |
| Completed |
NCT01262391 -
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
|
Phase 1 | |
| Completed |
NCT04528784 -
Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis
|
N/A | |
| Completed |
NCT02849418 -
Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity
|
Phase 3 | |
| Recruiting |
NCT05968885 -
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
|
Phase 4 |