Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
58
Administered as a tablet or capsule
Fortrea Clinical Research Unit
Dallas, Texas, United States
Maximum observed plasma concentration (Cmax)
Time frame: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Time frame: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Predose and up to 48 hours postdose up to Day 10
Time of the maximum observed plasma concentration (Tmax)
Time frame: Predose and up to 48 hours postdose up to Day 10
Apparent terminal elimination half-life (t1/2)
Time frame: Predose and up to 48 hours postdose up to Day 10
Apparent volume of distribution (Vz/F)
Time frame: Predose and up to 48 hours postdose up to Day 10
Rate of decrease of concentration in the terminal phase (λz)
Time frame: Predose and up to 48 hours postdose up to Day 10
Apparent oral clearance (CL/F)
Time frame: Predose and up to 48 hours postdose up to Day 10
Number of participants with adverse events (AEs)
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant laboratory values
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Laboratory values are based on hematology, clinical chemistry, and urinalysis test results
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant electrocardiogram (ECG) results
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant vital sign measurements
Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature
Time frame: Up to 30 days after last dose; up to approximately 7 weeks