A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples
|ClinicalTrials.gov Identifier: NCT02189330|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : July 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Tafamidis||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
20 mg of current commercial formulation.
|Experimental: Tafamudus Free Acid||
12.2 mgA free acid tablet.
|Experimental: 20 mg new soft gelatin capsule||
20 mg new soft gelatin capsule.
|Experimental: 4 capsules of 20 mg tafamidis of commercial formulation||
4 capsules of 20 mg tafamidis of current commercial formulation.
|Experimental: 4 capsules of 12.2 mg tafamidis of free acid tablet||
4 capsules of 12.2 mg tafamidis of free acid tablet..
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 168 hours ]AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 168 hours ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 168 hours ]Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 6 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189330
|Pfizer Investigational Site|
|Brussels, Belgium, B-1070|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|