A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 25-mg Tablets Relative to One 50-mg Tablet

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01273506
First received: January 7, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate the bioequivalence of a 50-mg tapentadol (CG5503) dose administered as two 25-mg ER, TRF tablets relative to one 50-mg ER TRF tablet in healthy Japanese male participants.


Condition Intervention Phase
Healthy Volunteer
Drug: tapentadol (CG5503) ER 25-mg TRF
Drug: tapentadol (CG5503) ER 50-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, Two-Way Crossover Study to Assess the Bioequivalence of Tapentadol Given as Two 25-mg Extended-Release Tamper-Resistant Formulation (TRF) Tablets Relative to One 50-mg Extended-Release TRF Tablet in Healthy Japanese Male Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pharmacokinetic profile, as measured by Cmax, tmax, AUC, t1/2, kel, AUMC, and MRT [ 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 5.5 weeks) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2010
Study Completion Date: February 2011
Arms Assigned Interventions
Experimental: 001
tapentadol (CG5503) ER 25-mg TRF 50 mg TRF single oral dose
Drug: tapentadol (CG5503) ER 25-mg TRF
50 mg TRF single oral dose
Experimental: 002
tapentadol (CG5503) ER 50-mg TRF 50 mg TRF single oral dose
Drug: tapentadol (CG5503) ER 50-mg TRF
50 mg TRF single oral dose

Detailed Description:

This is an open-label (all people know the identity of the intervention), single-center, randomized (the study drug is assigned by chance), 2-way crossover study (participants may receive different interventions sequentially during the trial). All participants will receive a single 50-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 25-mg TRF tablets and one 50-mg TRF tablet. All participants will be randomly assigned to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in each period:

Treatment A: two tapentadol (CG5503) ER 25-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 50-mg TRF tablet, administered as a single oral dose under fasted condition 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:

  • 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 mm Hg systolic, inclusive, and between 50 and 90 mm Hg diastolic, inclusive

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273506

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: NCT01273506     History of Changes
Other Study ID Numbers: CR017599, R331333PAI1062
Study First Received: January 7, 2011
Last Updated: March 12, 2012
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 August 19, 2014