Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01273532
Brief Summary:
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.
Detailed Description:
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:
NCT01273532
Study Brief:
Protocol Section:
NCT01273532