A Study to Compare the Bioequivalence of 50-mg Tapentadol (CG5503) Dose Administered as Two 50-mg Tablets Relative to One 100-mg Tablet

NCT ID: NCT01273532

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-03-31

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.

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 100-mg dose of tapentadol (CG5503) during 2 periods, in randomized order, as two 50-mg TRF tablets and one 100-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 50-mg TRF tablets, administered as a single oral dose under fasted condition Treatment B: one tapentadol (CG5503) ER 100-mg TRF tablet, administered as a single oral dose under fasted condition Each period will be separated by 7 - 14 days

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

001

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

Group Type: EXPERIMENTAL

tapentadol (CG5503) ER 50-mg TRF

Intervention Type: DRUG

100 mg TRF single oral dose

002

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

Interventions

tapentadol (CG5503) ER 100-mg TRF

100mg TRF single oral dose

Intervention Type: DRUG

tapentadol (CG5503) ER 50-mg TRF

100 mg TRF single oral dose

Intervention Type: DRUG

Eligibility 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 mmHg systolic, inclusive, and between 50 and 90 mmHg 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

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

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Other Identifiers

R331333PAI1063

Identifier Type: -

Identifier Source: secondary_id

CR017602

Identifier Type: -

Identifier Source: org_study_id