Overview

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

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Tapentadol
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