The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-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 100-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 50-mg TRF tablets and one 100-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 50-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 100-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
100mg TRF single oral dose
100 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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