Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• Experimental
  Treatment Sequence 1 : ABAB

  Participants will receive 140 milligram (mg) of ibrutinib administered as one IMBRUVICA 140-mg oral capsule (Treatment A) in Period 1, 140 mg of ibrutinib administered as one ibrutinib 140-mg oral tablet (Treatment B) in Period 2, then Treatment A in period 3 and then followed by Treatment B in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.

  Drug: Ibrutinib · Drug: IMBRUVICA

• Experimental
  Treatment Sequence 2 : BABA

  Participants will receive (Treatment B) Period 1, then Treatment A in Period 2, then Treatment B in Period 3 and then followed by Treatment A in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.

  Drug: Ibrutinib · Drug: IMBRUVICA

Interventions

• DrugIbrutinib

  Ibrutinib (test treatment) 140 milligram (mg), tablet.

• DrugIMBRUVICA

  IMBRUVICA (reference treatment), 140-mg capsule

  Also known as: Ibrutinib

Primary outcomes

1. Area Under Concentration from time zero to the last quantifiable (AUC [0-last])

   Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

   Time frame: Predose up to Day 3

2. Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

   The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C (0-last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.

   Time frame: Predose up to Day 3

3. Maximum Observed Analyte Concentration (Cmax)

   Maximum observed analyte concentration will be assessed.

   Time frame: Predose up to Day 3

4. Time to Reach Maximum Concentration (Tmax)

   Tmax is defined as actual sampling time to reach maximum observed analyte concentration will be assessed.

   Time frame: Predose up to Day 3

5. Apparent Terminal Elimination Halflife (t1/2term)

   The elimination halflife (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (λz).

   Time frame: Predose up to Day 3

6. Apparent Terminal Elimination Rate Constant (lambda z)

   Apparent terminal elimination rate constant, estimated by linear regression using the terminal loglinear phase of the log transformed concentration versus time data.

   Time frame: Predose up to Day 3

Secondary outcomes

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

   Time frame: Approximately 59 days