Pharmacokinetics and Relative Bioavailability Study

Phase 1

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: tolterodine tartrate

• Registration Number: NCT01521767
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	tolterodine tartrate	4 mg tolterodine extended release capsules, administered with water and under fasting condition.
B	tolterodine tartrate	4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition.
C	tolterodine tartrate	4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition.
E	tolterodine tartrate	4 mg MPB-RR1, administered with water and under fasting condition.
D	tolterodine tartrate	4 mg MPB-RR1, administered without water and under fed condition.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore