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

NCT01981278 | Completed Phase 1

• 2 other identifiers: CR100458R331333-PAI-1061
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy; Tapentadol; Bioequivalence; Fasted

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Plasma Concentration (Cmax) of tapentadol

  Cmax is defined as maximum observed analyte concentration.

  Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast) of tapentadol

  AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of tapentadol

  The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.

  Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of tapentadol

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Predose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 hours post-dose

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 5.5 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Tapentadol ER 250-mg tamper-resistant formulation (TRF) tablet will be administered as a single oral dose under fasted condition.

Drug: Tapentadol ER 250-mg TRF tablet

Treatment B

EXPERIMENTAL

Tapentadol ER 250-mg prolonged-release formulation 2 (PR2) tablet will be administered as a single oral dose under fasted condition.

Drug: Tapentadol ER 250-mg PR2 tablet

Interventions

Tapentadol ER 250-mg TRF tablet DRUG

Participants will receive single oral dose of tapentadol ER 250-mg TRF tablet on Day 1 of each treatment period.

Treatment A

Tapentadol ER 250-mg PR2 tablet DRUG

Participants will receive single oral dose of tapentadol PR2 250-mg tablet on Day 1 of each treatment period.

Treatment B

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (1)