<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452838</url>
  </required_header>
  <id_info>
    <org_study_id>A0221115</org_study_id>
    <secondary_id>2019-001909-24</secondary_id>
    <nct_id>NCT04452838</nct_id>
  </id_info>
  <brief_title>Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer</brief_title>
  <official_title>A PHASE 1, OPEN-LABEL, SINGLE-DOSE, CROSSOVER STUDY TO ASSESS THE BIOEQUIVALENCE UNDER FED AND FASTED CONDITIONS OF FESOTERODINE BEADS-IN-CAPSULE SR7 AND SR4 FORMULATIONS, THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF THE BEADS-IN-CAPSULE SR7 FORMULATION AND TO ESTIMATE THE BIOAVAILABILITY OF SR7 BEADS SPRINKLED ON APPLE SAUCE RELATIVE TO THE BEADS-IN-CAPSULE SR7 FORMULATION ADMINISTERED INTACT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open Label, Single-Dose, Crossover Study To Assess The Bioequivalence Under Fed And Fasted&#xD;
      Conditions Of The Fesoterodine Beads-In-Capsule (BIC) SR4 And SR7 Formulations And To&#xD;
      Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The&#xD;
      Beads-In-Capsule SR7 Formulation Administered Intact.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After oral administration, fesoterodine is not detected in plasma as it is rapidly and&#xD;
      extensively hydrolyzed by non-specific esterases to its primary active metabolite&#xD;
      5-hydroxymethyl tolterodine (5-HMT) . Therefore characterization of the rate and extent of&#xD;
      absorption of the test and reference fesoterodine formulations will be based on&#xD;
      pharmacokinetic parameters of 5-HMT derived from the 5-HMT concentration-time profiles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Actual">January 4, 2021</completion_date>
  <primary_completion_date type="Actual">January 4, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a Phase 1 randomized, open-label, single-dose crossover study in healthy participants. A two stage approach outlined below will be followed:&#xD;
Part A (Cohort 1): This part of the study is a 2 sequence, 4 period, crossover design.&#xD;
Part B (Cohort 2): This part of the study is a 4 sequence, 4 period, crossover design. Participants will be randomized to 1 of 4 possible treatment sequences. If bioequivalence (BE) criteria for the comparison of the BIC SR7 formulation with the BIC SR4 formulation administered in the fasted state are met in Part A, the formulations will be considered bioequivalent in the fasted state and only the first two periods of Part B will be conducted. Part B (all periods) may not be conducted if the AUCinf or Cmax Percent Geometric Mean Ratio GMR is less than 90% and greater than 111% and/or if variability suggest a highly variable drug (e.g., greater than 30%) because BE demonstration may not be possible with a reasonably sized 4 sequence 4 period study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AUCinf of 5-HMT</measure>
    <time_frame>0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours</time_frame>
    <description>Area under the plasma concentration-time curve from time zero extrapolated to infinity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUClast of 5-HMT</measure>
    <time_frame>0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours</time_frame>
    <description>Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of 5-HMT</measure>
    <time_frame>0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours</time_frame>
    <description>Maximum Observed Plasma Concentration</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Neurogenic Detrusor Overactivity</condition>
  <arm_group>
    <arm_group_label>Cohort 1 Sequence 1 (Part A)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment Sequence A,B,C and D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 Sequence 2 (Part A)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment Sequence B, A,C and D</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Sequence 1 (Part B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment Sequence E, F, G, and H</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Sequence 2 (Part B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment Sequence E, F, H and G</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Sequence 3 (Part B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment Sequence F, E, G, and H</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 Sequence 4 (Part B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment sequence F, E, H, and G</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)</intervention_name>
    <description>4 mg administered under fasted condition.</description>
    <arm_group_label>Cohort 1 Sequence 1 (Part A)</arm_group_label>
    <arm_group_label>Cohort 1 Sequence 2 (Part A)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 1 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 2 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 3 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 4 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)</intervention_name>
    <description>4 mg administered under fasted conditions.</description>
    <arm_group_label>Cohort 1 Sequence 1 (Part A)</arm_group_label>
    <arm_group_label>Cohort 1 Sequence 2 (Part A)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 1 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 2 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 3 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 4 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)</intervention_name>
    <description>4 mg administered under fed conditions.</description>
    <arm_group_label>Cohort 1 Sequence 1 (Part A)</arm_group_label>
    <arm_group_label>Cohort 1 Sequence 2 (Part A)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 1 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 2 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 3 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 4 (Part B)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)</intervention_name>
    <description>4 mg sprinkled on apple sauce administered under fasting conditions</description>
    <arm_group_label>Cohort 1 Sequence 1 (Part A)</arm_group_label>
    <arm_group_label>Cohort 1 Sequence 2 (Part A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fesoterodine BIC SR4 fed (Treatment E in Part B)</intervention_name>
    <description>4 mg administered under fed conditions</description>
    <arm_group_label>Cohort 2 Sequence 1 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 2 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 3 (Part B)</arm_group_label>
    <arm_group_label>Cohort 2 Sequence 4 (Part B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of&#xD;
             signing the informed consent document (ICD).&#xD;
&#xD;
          2. Male and female participants who are overtly healthy as determined by medical&#xD;
             evaluation including medical history, physical examination, and laboratory tests.&#xD;
&#xD;
          3. Participants who are willing and able to comply with all scheduled visits, treatment&#xD;
             plan, laboratory tests, lifestyle considerations, and other study procedures. Weight:&#xD;
&#xD;
          4. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lb).&#xD;
&#xD;
          5. Capable of giving signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or&#xD;
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at the time of dosing).&#xD;
&#xD;
          2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).&#xD;
&#xD;
          3. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;&#xD;
             positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core&#xD;
             antibody (HBcAb) or hepatitis C antibody (HCVAb). A positive serology for hepatitis B&#xD;
             surface antibody (HBsAb) as a result of Hepatitis B vaccination is allowed.&#xD;
&#xD;
          4. Other acute or chronic medical or psychiatric condition including recent (within the&#xD;
             past year) or active suicidal ideation or behavior or laboratory abnormality that may&#xD;
             increase the risk associated with study participation or investigational product&#xD;
             administration or may interfere with the interpretation of study results and, in the&#xD;
             judgment of the investigator, would make the participant inappropriate for entry into&#xD;
             this study.&#xD;
&#xD;
          5. History of allergy or hypersensitivity to fesoterodine fumarate or tolterodine&#xD;
             tartrate, soya, or any of the excipients in the investigational drug product.&#xD;
&#xD;
          6. History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention,&#xD;
             severe ulcerative colitis and toxic megacolon.&#xD;
&#xD;
          7. Evidence or history of clinically significant urologic disease: urinary retention,&#xD;
             obstructive disturbance of bladder emptying, micturition disturbance, nocturia or&#xD;
             pollakiuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary&#xD;
             tract infections).&#xD;
&#xD;
          8. Use of prescription or nonprescription drugs and dietary and herbal supplements within&#xD;
             7 days or 5 half-lives (whichever is longer) prior to the first dose of&#xD;
             investigational product.&#xD;
&#xD;
          9. Previous administration with an investigational drug within 30 days (or as determined&#xD;
             by the local requirement) or 5 half-lives preceding the first dose of investigational&#xD;
             product used in this study (whichever is longer).&#xD;
&#xD;
         10. A positive urine drug test, as confirmed by a single repeat.&#xD;
&#xD;
         11. Screening supine blood pressure (BP) greater than or equal to 140 mm Hg (systolic) or&#xD;
             greater than or equal to 90 mm Hg (diastolic), following at least 5 minutes of supine&#xD;
             rest. If BP is greater than or equal to 140 mm Hg (systolic) or greater than or equal&#xD;
             to 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the&#xD;
             3 BP values should be used to determine the participant's eligibility.&#xD;
&#xD;
         12. Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant&#xD;
             abnormalities that may affect participant safety or interpretation of study results&#xD;
             (eg, baseline corrected QT (QTc) interval &gt;450 msec, complete left bundle branch block&#xD;
             [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval&#xD;
             changes suggestive of myocardial ischemia, second- or third-degree atrioventricular&#xD;
             [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline&#xD;
             uncorrected QT interval is greater than 450 msec, this interval should be&#xD;
             rate-corrected using the Fridericia method and the resulting corrected QT (QTcF)&#xD;
             should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS&#xD;
             exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc&#xD;
             or QRS values should be used to determine the participant's eligibility.&#xD;
             Computer-interpreted ECGs should be overread by a physician experienced in reading&#xD;
             ECGs before excluding participants.&#xD;
&#xD;
         13. Participants with ANY of the following abnormalities in clinical laboratory tests at&#xD;
             Screening, as assessed by the study-specific laboratory and confirmed by a single&#xD;
             repeat test, if deemed necessary:&#xD;
&#xD;
         14. Screening estimated glomerular filtration rate (eGFR) is less than or equal to 90 mL&#xD;
             /min/1.73 m2 for Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).&#xD;
&#xD;
         15. History of alcohol abuse or binge drinking and/or any other illicit drug use or&#xD;
             dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5&#xD;
             (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,&#xD;
             alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1&#xD;
             ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).&#xD;
&#xD;
         16. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 60 days prior to dosing.&#xD;
&#xD;
         17. Unwilling or unable to comply with the criteria in the Lifestyle Considerations&#xD;
             section of this protocol.&#xD;
&#xD;
         18. Investigator site staff members directly involved in the conduct of the study and&#xD;
             their family members, site staff members otherwise supervised by the investigator, or&#xD;
             Pfizer employees, including their family members, directly involved in the conduct of&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brussels Clinical Research Unit</name>
      <address>
        <city>Brussels</city>
        <state>Bruxelles-capitale, Région DE</state>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A0221115</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase I, Fesoterodine beads- in-capsule, Bioequivalence, Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fesoterodine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452838
org study id: A0221115
secondary id: 2019-001909-24
nct id: NCT04452838
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open Label, Single-Dose, Crossover Study To Assess The Bioequivalence Under Fed And Fasted
      Conditions Of The Fesoterodine Beads-In-Capsule (BIC) SR4 And SR7 Formulations And To
      Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The
      Beads-In-Capsule SR7 Formulation Administered Intact.
After oral administration, fesoterodine is not detected in plasma as it is rapidly and
      extensively hydrolyzed by non-specific esterases to its primary active metabolite
      5-hydroxymethyl tolterodine (5-HMT) . Therefore characterization of the rate and extent of
      absorption of the test and reference fesoterodine formulations will be based on
      pharmacokinetic parameters of 5-HMT derived from the 5-HMT concentration-time profiles.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a Phase 1 randomized, open-label, single-dose crossover study in healthy participants. A two stage approach outlined below will be followed:
Part A (Cohort 1): This part of the study is a 2 sequence, 4 period, crossover design.
Part B (Cohort 2): This part of the study is a 4 sequence, 4 period, crossover design. Participants will be randomized to 1 of 4 possible treatment sequences. If bioequivalence (BE) criteria for the comparison of the BIC SR7 formulation with the BIC SR4 formulation administered in the fasted state are met in Part A, the formulations will be considered bioequivalent in the fasted state and only the first two periods of Part B will be conducted. Part B (all periods) may not be conducted if the AUCinf or Cmax Percent Geometric Mean Ratio GMR is less than 90% and greater than 111% and/or if variability suggest a highly variable drug (e.g., greater than 30%) because BE demonstration may not be possible with a reasonably sized 4 sequence 4 period study.
primary purpose: Other
masking: None (Open Label)
measure: AUCinf of 5-HMT
time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
description: Area under the plasma concentration-time curve from time zero extrapolated to infinity.
measure: AUClast of 5-HMT
time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
description: Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.
measure: Cmax of 5-HMT
time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
description: Maximum Observed Plasma Concentration
arm group label: Cohort 1 Sequence 1 (Part A)
arm group type: Other
description: Treatment Sequence A,B,C and D
arm group label: Cohort 1 Sequence 2 (Part A)
arm group type: Other
description: Treatment Sequence B, A,C and D
arm group label: Cohort 2 Sequence 1 (Part B)
arm group type: Other
description: Treatment Sequence E, F, G, and H
arm group label: Cohort 2 Sequence 2 (Part B)
arm group type: Other
description: Treatment Sequence E, F, H and G
arm group label: Cohort 2 Sequence 3 (Part B)
arm group type: Other
description: Treatment Sequence F, E, G, and H
arm group label: Cohort 2 Sequence 4 (Part B)
arm group type: Other
description: Treatment sequence F, E, H, and G
intervention type: Drug
intervention name: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)
description: 4 mg administered under fasted condition.
arm group label: Cohort 1 Sequence 1 (Part A)
arm group label: Cohort 1 Sequence 2 (Part A)
arm group label: Cohort 2 Sequence 1 (Part B)
arm group label: Cohort 2 Sequence 2 (Part B)
arm group label: Cohort 2 Sequence 3 (Part B)
arm group label: Cohort 2 Sequence 4 (Part B)
intervention type: Drug
intervention name: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)
description: 4 mg administered under fasted conditions.
arm group label: Cohort 1 Sequence 1 (Part A)
arm group label: Cohort 1 Sequence 2 (Part A)
arm group label: Cohort 2 Sequence 1 (Part B)
arm group label: Cohort 2 Sequence 2 (Part B)
arm group label: Cohort 2 Sequence 3 (Part B)
arm group label: Cohort 2 Sequence 4 (Part B)
intervention type: Drug
intervention name: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)
description: 4 mg administered under fed conditions.
arm group label: Cohort 1 Sequence 1 (Part A)
arm group label: Cohort 1 Sequence 2 (Part A)
arm group label: Cohort 2 Sequence 1 (Part B)
arm group label: Cohort 2 Sequence 2 (Part B)
arm group label: Cohort 2 Sequence 3 (Part B)
arm group label: Cohort 2 Sequence 4 (Part B)
intervention type: Drug
intervention name: Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)
description: 4 mg sprinkled on apple sauce administered under fasting conditions
arm group label: Cohort 1 Sequence 1 (Part A)
arm group label: Cohort 1 Sequence 2 (Part A)
intervention type: Drug
intervention name: Fesoterodine BIC SR4 fed (Treatment E in Part B)
description: 4 mg administered under fed conditions
arm group label: Cohort 2 Sequence 1 (Part B)
arm group label: Cohort 2 Sequence 2 (Part B)
arm group label: Cohort 2 Sequence 3 (Part B)
arm group label: Cohort 2 Sequence 4 (Part B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
country: Belgium
url: https://pmiform.com/clinical-trial-info-request?StudyID=A0221115
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
mesh term: Malnutrition
mesh term: Fesoterodine
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.