Pharmacokinetics and Relative Bioavailability Study

Study Overview
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Brief Summary
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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

Detailed Description
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Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules

Official Title
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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

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: tolterodine tartrate
* Drug: tolterodine tartrate
* Drug: tolterodine tartrate
* Drug: tolterodine tartrate
* Drug: tolterodine tartrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>4 mg tolterodine extended release capsules, administered with water and under fasting condition. | Drug: tolterodine tartrate<br>* 4 mg single dose of extended release capsules<br>|
| Experimental: B<br>4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition. | Drug: tolterodine tartrate<br>* 4 mg single dose of microspheres in powder blend<br>|
| Experimental: C<br>4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition. | Drug: tolterodine tartrate<br>* 4 mg single dose of microspheres in powder blend<br>|
| Experimental: D<br>4 mg MPB-RR1, administered without water and under fed condition. | Drug: tolterodine tartrate<br>* 4 mg single dose of microspheres in powder blend<br>|
| Experimental: E<br>4 mg MPB-RR1, administered with water and under fasting condition. | Drug: tolterodine tartrate<br>* 4 mg single dose of microspheres in powder blend<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tolterodine |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) of tolterodine |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of tolterodine. |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 5-HMT |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of 5-HMT |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) of 5-HMT |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of tolterodine |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of 5-HMT |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Plasma Decay Half-Life (t1/2) of tolterodine |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 
| Plasma Decay Half-Life (t1/2) of 5-HMT |  | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 30, 36 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, relative bioavailability, tolterodine microspheres in powder blend, Overactive Urinary Bladder