An open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fed conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Suspension
Modified release tablets
Modified release tablets
Pfizer Clinical Research Unit
Brussels, Belgium
Maximum Observed Plasma Concentration (Cmax) for PF-06865571
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Time to Reach Maximum Observed Concentration for PF-06865571
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06865571
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time for PF-06865571
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Plasma Decay Half-Life (t1/2) for PF-06865571
Plasma Decay Half-Life (t1/2)
Time frame: 0,0.5,1,2,3,4,6,8,12,24,36,48 hours post dose in each period
Number of subjects with adverse events (AEs)
Number of participants with reported adverse events
Time frame: Baseline up to 35 days after last dose
Number of subjects with laboratory tests findings of potential clinical importance
Number of participants with potentially clinically important laboratory test findings
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Immediate release tablets
Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication
Number of subjects with vital signs findings of potential clinical importance
Number of participants with potentially clinically important vital sign measurements
Time frame: Baseline (Day 0) up to 48 hours after last dose of study medication