A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet

NCT01900587 ↗

Phase 1 Completed 64 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER) tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release formulation 2 (PR2) tablet, in healthy participants.

Timeline

Start: 2010-07
Primary completion: 2010-08
Completion: 2010-08

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tapentadol	Small molecule	50 mg	—

Indications

No indication recorded.