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 |
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