Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 4 mg fesoterodine IR beads in capsule under fasting condition |
|
| B | Experimental | 4 mg fesoterodine 10% coated ER beads in capsule under fasting condition |
|
| C | Experimental | 4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. |
|
| D | Experimental | 4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. |
|
| E | Experimental | 4 mg fesoterodine ER tablets under fasting condition. |
|
| F | Experimental | 4 mg fesoterodine TBD % coated ER beads in capsule under fed condition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fesoterodine | Drug | single dose of beads in capsule |
| |
| fesoterodine |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT]) | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT. | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
| Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose | |
| Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER | Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG001 | Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG002 | Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR | Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG003 | Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER | Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG004 | Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER | Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG005 | Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER | Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG006 | Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG007 | Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet | Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG008 | Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR | Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG009 | Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER | Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained. |
| FG010 | Fesoterodine 4 mg 10% ER Fed | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part I- First Intervention Period |
| |||||||||||||
| Washout Period (At Least 3 Days) |
| |||||||||||||
| Second Intervention Period |
| |||||||||||||
| Washout Period (At Least 3 Days) |
| |||||||||||||
| Third Intervention Period |
| |||||||||||||
| Washout Period (At Least 3 Days) |
| |||||||||||||
| Fourth Intervention Period |
| |||||||||||||
| Washout Period (At Least 3 Days) |
| |||||||||||||
| Fifth Intervention Period |
| |||||||||||||
| Washout Period (Approximately 2 Weeks) |
| |||||||||||||
| Part II- Sixth Intervention Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT]) | AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). | Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine 4 mg IR-BIC Fasted | Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C526675 | fesoterodine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
single dose of beads in capsule |
|
| fesoterodine | Drug | single dose of beads in capsule |
|
| fesoterodine | Drug | single dose of beads in capsule |
|
| fesoterodine | Drug | single dose of tablet |
|
| fesoterodine | Drug | single dose of beads in capsule |
|
| 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Fesoterodine 4 mg 10% ER-BIC Fasted | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. |
| OG002 | Fesoterodine 4 mg 15% ER-BIC Fasted | Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. |
| OG003 | Fesoterodine 4 mg 20% ER-BIC Fasted | Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. |
| OG004 | Fesoterodine 4 mg ER Tablet Fasted | Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods. |
| OG005 | Fesoterodine 4 mg 10% ER-BIC Fed | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period. |
|
|
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT. | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Standard Deviation | ng*hr/mL | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
|
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT) | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Standard Deviation | ng/mL | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
|
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT) | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Median | Full Range | hr | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
|
|
|
| Secondary | Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean. | Posted | Mean | Standard Deviation | hr | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose |
|
|
|
| 0 |
| 20 |
| 7 |
| 20 |
| EG001 | Fesoterodine 4 mg 10% ER-BIC Fasted | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. | 0 | 20 | 4 | 20 |
| EG002 | Fesoterodine 4 mg 15% ER-BIC Fasted | Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. | 0 | 20 | 6 | 20 |
| EG003 | Fesoterodine 4 mg 20% ER-BIC Fasted | Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods. | 0 | 20 | 0 | 20 |
| EG004 | Fesoterodine 4 mg ER Tablet Fasted | Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods. | 0 | 20 | 4 | 20 |
| EG005 | Fesoterodine 4 mg 10% ER-BIC Fed | Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period. | 0 | 20 | 6 | 20 |
| Dry mouth | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v13.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v13.1 | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA v13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test. | Ratio of Adjusted Means | 103.71 | 2-Sided | 90 | 95.48 | 112.65 | No | Superiority or Other |
| Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test. | Ratio of Adjusted Means | 66.87 | 2-Sided | 90 | 61.56 | 72.63 | No | Superiority or Other |
| Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test. | Ratio of Adjusted Means | 28.34 | 2-Sided | 90 | 26.09 | 30.78 | No | Superiority or Other |
| Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test. | Ratio of Adjusted Means | 114.70 | 2-Sided | 90 | 106.99 | 122.97 | No | Superiority or Other |
| Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test. | Ratio of Adjusted Means | 134.83 | 2-Sided | 90 | 120.31 | 151.09 | No | Superiority or Other |
| Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test. | Ratio of Adjusted Means | 48.58 | 2-Sided | 90 | 43.35 | 54.44 | No | Superiority or Other |
| Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test. | Ratio of Adjusted Means | 14.38 | 2-Sided | 90 | 12.83 | 16.11 | No | Superiority or Other |
| Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test. | Ratio of Adjusted Means | 171.06 | 2-Sided | 90 | 115.82 | 187.78 | No | Superiority or Other |