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Completed

NCT Number: NCT02160158

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

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).

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fesoterodine ER (fasted)

Drug

Commercial Fesoterodine ER 4 mg (single dose)

Fesoterodine SR3 (fasted)

Drug

Fesoterodine SR3 4 mg (single dose)

Fesoterodine SR3 (fed)

Drug

Fesoterodine SR3 4 mg (single dose) with high-fat meal

Fesoterodine ER (fed)

Drug

Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

Fesoterodine SR3 (sprinkle)

Drug

Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce

Fesoterodine SR4 (fasted)

Drug

Fesoterodine SR4 4 mg (single dose)

Fesoterodine SR4 (fed)

Drug

Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal

Fesoterodine SR4 (sprinkle)

Drug

Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce

Primary outcomes

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

    Time frame: 48 hours

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 48 hours

Secondary outcomes

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

    Time frame: 48 hours

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 48 hours

  3. Plasma Decay Half-Life (t1/2)

    Time frame: 48 hours

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2014
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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