A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.

• 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:

• Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol

• Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters performed within 21 days before study drug administration

• Women must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of each treatment period

• Must agree to use an adequate contraception method and to not donate sperm during the study and for 3 months after receiving the last dose of study medication

• Body mass index (BMI) (weight [kg]/height [m2]) between 20 and 28 kg/m2, inclusive, and body weight not less than 50 kg

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, or severe traumatic brain injury within 15 years of screening, or severe traumatic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness or symptoms

• History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection

• History of clinically significant allergies, especially known hypersensitivity/intolerance or contraindications to opioids, opioid antagonists (eg, naloxone), benzodiazepines (eg, diazepam, clonazepam, lorazepam), any study drug formulation component, any of the excipients of the formulation, or heparin

• Women who plan to become pregnant during the study, or who are breast-feeding

• Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies