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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01309425
First received: March 3, 2011
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
 Drug: tapentadol (CG5503) ER two 100-mg TRF
Drug: tapentadol (CG5503) ER 50-mg TRF
Drug: tapentadol (CG5503) ER 25-mg TRF
Drug: tapentadol (CG5503) ER 100-mg TRF
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2 [ Time Frame: Two days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Time of screening to end of treatment (up to 9.5 weeks) ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: February 2011
Study Completion Date: May 2011
Arms Assigned Interventions
Experimental: 001
tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose
 Drug: tapentadol (CG5503) ER 25-mg TRF
25mg TRF single oral dose
Experimental: 002
tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose
 Drug: tapentadol (CG5503) ER 50-mg TRF
50mg TRF single oral dose
Experimental: 003
tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose
 Drug: tapentadol (CG5503) ER 100-mg TRF
100mg TRF single oral dose
Experimental: 004
tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose
 Drug: tapentadol (CG5503) ER two 100-mg TRF
200mg TRF single oral dose

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese and Korean male volunteers, inclusive
  • Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg
  • Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and paternal grandparents are Japanese.
  • Korean volunteers must have resided outside of Korea for no more than 5 years and their parents and maternal and paternal grandparents are Korean.

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease
  • History of hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities
  • History of significant pulmonary disease, including bronchospastic respiratory disease
  • History of diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol-acetaminophen, within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309425

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Senior Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01309425     History of Changes
Other Study ID Numbers: CR017782, R331333PAI1064
Study First Received: March 3, 2011
Last Updated: November 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
tapentadol
NUCYNTA
CG5503
 R331333
pharmacokinetics
healthy volunteer

ClinicalTrials.gov processed this record on May 22, 2013