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

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:

Drug Information available for: Tapentadol hydrochloride Tapentadol

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, 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

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 May 22, 2013