Pharmacokinetics and Relative Bioavailability Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01521767
First received: January 17, 2012
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: tolterodine tartrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
4 mg tolterodine extended release capsules, administered with water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of extended release capsules
Experimental: B
4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: C
4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: D
4 mg MPB-RR1, administered without water and under fed condition.
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend
Experimental: E
4 mg MPB-RR1, administered with water and under fasting condition.
Drug: tolterodine tartrate
4 mg single dose of microspheres in powder blend

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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521767

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521767     History of Changes
Other Study ID Numbers: A6121196
Study First Received: January 17, 2012
Last Updated: January 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetics
relative bioavailability
tolterodine microspheres in powder blend
Overactive Urinary Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 21, 2014