A Study to Compare the Dose-proportionality of Tapentadol (CG5503) in Healthy Japanese and Korean Male Volunteers

Healthy Volunteer Clinical Trial

Official title: A Single-Dose, Open-Label, Randomized, Four-Way Crossover Study to Assess the Dose-Proportionality of the Pharmacokinetics of Tapentadol, Given as Tamper-Resistant Tablets, in Healthy Japanese and Korean Male Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.

Clinical Trial Description

This is a single-dose, open-label, single-center, randomized, four-way crossover study, ie, participants and investigator know the identity of the drug, which is assigned by chance, like flipping a coin, and participants may receive different interventions sequentially during the study. The study will consist of 4 treatment periods. A single dose of tapentadol (CG5503) will be administered orally with 240 mL of water under fasted conditions. All participants will receive 1 of the following 4 oral treatments in each period.

Treatment A: One 25-mg tablet (25 mg) of tapentadol (CG5503) Treatment B: One 50-mg tablet (50 mg) of tapentadol (CG5503) Treatment C: One 100-mg tablet (100 mg) of tapentadol (CG5503) Treatment D: Two 100-mg tablets (200 mg) of tapentadol (CG5503) Each period will be separated by 7 - 14 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

• NCT number: NCT01309425
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 1
• Start date: February 2011
• Completion date: May 2011