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

NCT ID: NCT01309425

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Volunteer

Keywords

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tapentadol NUCYNTA CG5503 R331333 pharmacokinetics healthy volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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001

tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose

Group Type EXPERIMENTAL

tapentadol (CG5503) ER 25-mg TRF

Intervention Type DRUG

25mg TRF single oral dose

002

tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose

Group Type EXPERIMENTAL

tapentadol (CG5503) ER 50-mg TRF

Intervention Type DRUG

50mg TRF single oral dose

003

tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose

Group Type EXPERIMENTAL

tapentadol (CG5503) ER 100-mg TRF

Intervention Type DRUG

100mg TRF single oral dose

004

tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose

Group Type EXPERIMENTAL

tapentadol (CG5503) ER two 100-mg TRF

Intervention Type DRUG

200mg TRF single oral dose

Interventions

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tapentadol (CG5503) ER two 100-mg TRF

200mg TRF single oral dose

Intervention Type DRUG

tapentadol (CG5503) ER 50-mg TRF

50mg TRF single oral dose

Intervention Type DRUG

tapentadol (CG5503) ER 25-mg TRF

25mg TRF single oral dose

Intervention Type DRUG

tapentadol (CG5503) ER 100-mg TRF

100mg TRF single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries

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United States

Other Identifiers

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R331333PAI1064

Identifier Type: -

Identifier Source: secondary_id

CR017782

Identifier Type: -

Identifier Source: org_study_id