The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503) dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy Japanese male participants.
This is an open-label (all people know the identity of the intervention), single-center, randomized (the study drug is assigned by chance), 2-way crossover study (participants may receive different interventions sequentially during the trial). All participants will receive a single 50-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 25-mg TRF tablets and one 50-mg TRF tablet. All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in each period: Treatment A: two tapentadol (CG5503) ER 25-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 50-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
30
50 mg TRF single oral dose
50 mg TRF single oral dose
Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC, and MRT
Time frame: two days
Number of participants with adverse events
Time frame: time of screening to end of treatment (up to 5.5 weeks)
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