MedTrace Logo

Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

NCT00807118 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2010-03-24

No results posted yet for this study

Summary

Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission.

Conditions

  • Therapeutic Equivalency
  • Food

Interventions

DRUG

Fesoterodine

Single dose of 2 x 4 mg tab in formulation F under fed condition

DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation F under fed condition

DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation E(1) under fed condition

DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation F under fed condition

DRUG

Fesoterodine

Single dose of 2 x 4 mg tab in formulation F under fasted condition

DRUG

Fesoterodine

Single dose of 1 x 8 mg tab in formulation F under fasted condition

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Japan

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00807118 on ClinicalTrials.gov