NCT01273532

Brief Summary

The purpose of this study is to evaluate the bioequivalence of a 100-mg tapentadol (CG5503) dose administered as two 50-mg ER, TRF tablets relative to one 100-mg ER TRF tablet in healthy Japanese male participants.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

First QC Date

January 7, 2011

Last Update Submit

March 12, 2012

Conditions

Healthy Volunteer

Keywords

tapentadolNUCYNTACG5503R331333pharmacokineticshealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC and MRT

    Two days

Secondary Outcomes (1)

  • Number of participants with adverse events

    Time of screening to end of treatment (up to 5.5 weeks)

Study Arms (2)

001

EXPERIMENTAL

tapentadol (CG5503) ER 50-mg TRF 100 mg TRF single oral dose

Drug: tapentadol (CG5503) ER 50-mg TRF

002

EXPERIMENTAL

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

Drug: tapentadol (CG5503) ER 100-mg TRF

Interventions

tapentadol (CG5503) ER 100-mg TRFDRUG

100mg TRF single oral dose

002
tapentadol (CG5503) ER 50-mg TRFDRUG

100 mg TRF single oral dose

001

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese participants who have resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese, as determined by participant's verbal report
  • Deemed healthy on the basis of prestudy physical examination, medical history (including smoking habits), 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory parameters (serum chemistry, serology and hematology) performed within 21 days before study drug administration.
  • Must not impregnate their partners
  • Body mass index (BMI) (weight \[kg\]/height \[m2\]) between 18.5 and 25 kg/m2, inclusive, and body weight not less than 50 kg
  • Blood pressure (after the participant is supine for 5 minutes) between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive

You may not qualify if:

  • History of seizure disorder or epilepsy or ¿mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
  • history of ¿severe traumatic brain injury (consisting of 1 or more of the following: brain contusion
  • intracranial hematoma
  • or episode(s) of more than 24 hours duration of unconsciousness or posttraumatic amnesia) within 15 years of screening, or history of ¿severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms suggestive thereof
  • History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness
  • History of clinically significant allergies, especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists (e.g., naloxone), benzodiazepines (e.g., diazepam, clonazepam, lorazepam), any study drug formulation component, any of the excipients of the formulation, or heparin (should the use of a heparin lock be necessary)
  • History of, or a reason to believe a participant has a history of lifetime opioid abuse, or drug or alcohol abuse within the past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tapentadol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

December 1, 2010

Study Completion

March 1, 2011

Last Updated

March 13, 2012

Record last verified: 2012-03