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Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Fesoterodine ER (fasted) (Drug); Fesoterodine SR3 (fasted) (Drug); Fesoterodine SR3 (fed) (Drug); Fesoterodine ER (fed) (Drug); Fesoterodine SR3 (sprinkle) (Drug); Fesoterodine ER (fasted) (Drug); Fesoterodine SR4 (fasted) (Drug); Fesoterodine SR4 (fed) (Drug); Fesoterodine ER (fed) (Drug); Fesoterodine SR4 (sprinkle) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).

Clinical Details

Official title: Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half-Life (t1/2)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass

Index (BMI) of 17. 5 to 30. 5 kg/m2; and a total body weight >50 kg (110 lbs) Exclusion Criteria:

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or

5 half-lives (whichever is longer) prior to the first dose of study medication

- History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention,

severe ulcerative colitis and toxic megacolon

- Evidence or history of clinically significant urologic disease [urinary retention,

obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day

Locations and Contacts

Pfizer Clinical Research Unit, Brussels B-1070, Belgium
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2014
Last updated: January 14, 2015

Page last updated: August 23, 2015

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