NCT01900587

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

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess Bio-equivalence of a New Tapentadol Extended-Release (TRF) 50-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 50-mg Tablet Under Fasted Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-dose, open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-centre, randomized (like the flip of a coin; 50/50 chance of receiving a study treatment), and 2-way crossover (groups of participants receive two or more interventions in a particular order) study of a single-dose tapentadol in healthy participants under fasted conditions. The study consists of 3 parts: Screening (2 to 21 days before the study commences), Open-label Treatment (single-dose treatment on Day 1 of each period separated with wash-out period of 7 to 14 days) and End of study (Day 3 of treatment Period 2). The duration of participation in the study for an individual participant will be up to 5.5 weeks (including Screening). Participants will be randomly assigned to one of the 2 treatment sequence groups. Participants assigned to the first treatment sequence will receive tapentadol TRF 50 milligram (mg) tablet, and after a washout period, participants will receive tapentadol PR2 50-mg tablet. Participants assigned to the second treatment sequence will receive tapentadol PR2 50-mg tablet, and after washout period, participants will receive tapentadol TRF 50-mg tablet. Bio-equivalence will be primarily evaluated by pharmacokinetics parameters. Participant's safety will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tapentadol ER Tamper-resistant Formulation (TRF)	Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.
DRUG	Tapentadol ER Prolonged-Release 2 (PR2)	Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2013-07-16
• Last updated: 2013-11-01

Locations

1 site across 1 country: United States