A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|