Pharmacokinetics and Relative Bioavailability Study - Full Text View

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:

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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
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

Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013