A Bioequivalence Study Comparing Two Different Tafamidis Formulations

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tafamidis

• Registration Number: NCT02217813
• Lead Sponsor: Pfizer

Brief Summary

Each subject will be given tafamidis. After swallowing a single tafamidis capsule, tafamidis blood concentrations will be measured periodically for one week. After about 20 days, subjects will take a different form of tafamidis capsule and the process repeated. Tafamidis concentrations from the two different formulations will be compared to determine if they are approximately the same.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Study Start: 2014-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Healthy males or females of non-child bearing potential.
• Body Mass Index (BMI) of 17.5 to 30.5 Kg and total body weight more than 50 Kg (110 lbs).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. Tafamidis	Tafamidis	-
2. Tafamidis	Tafamidis	-

Primary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve (AUC)	168 hours	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)	168 hours

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax)	168 hours
Plasma Decay Half-Life (t1/2)	168 hours	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	168 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	168 hours	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium