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Pharmacokinetics and Relative Bioavailability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521767
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: tolterodine tartrate Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 2011
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521767     History of Changes
Other Study ID Numbers: A6121196
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

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 Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents