A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet

NCT01900587 | Completed Phase 1

• 2 other identifiers: CR100456R331333-PAI-1059
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER) tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release formulation 2 (PR2) tablet, in healthy participants.

Conditions

Healthy

Keywords

Healthy; Bio-equivalence; Tapentadol extended release; Tamper-resistant formulation

Outcome Measures

Primary Outcomes (3)

• Maximum Serum Concentration (C[max])

  The C(max) is the maximum serum concentration which will be observed at the defined time points.

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

• Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [infinity])

  The AUC (infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

• Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [last])

  The AUC (last) is the area under the serum concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

Secondary Outcomes (6)

• Time to Reach the Maximum Serum Concentration (T[max])

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

• Percentage of AUC(infinity)

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

• Elimination half-life period (t1/2)

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

• Terminal slope (Lambda [z])

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

• Time to Last Quantifiable Serum Concentration (T[last])

  Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 hours post-dose of study medication

Study Arms (2)

Tapentadol Extended release (ER) TRF then tapentadol ER PR2

EXPERIMENTAL

Single dose of tapentadol ER 50 milligram (mg), tamper-resistant formulation (TRF) tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, prolonged released (PR2) tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period.

Drug: Tapentadol ER Tamper-resistant Formulation (TRF); Drug: Tapentadol ER Prolonged-Release 2 (PR2)

Tapentadol ER PR2 then tapentadol ER TRF

EXPERIMENTAL

Single dose of tapentadol ER 50 milligram (mg), PR2 tablet will be administered under fasted condition in first treatment period; after that in second treatment period, single-dose of tapentadol ER 50 mg, TRF tablet will be administered under fasted condition. A washout period of 7 to 14 days will be maintained between each treatment period.

Drug: Tapentadol ER Tamper-resistant Formulation (TRF); Drug: Tapentadol ER Prolonged-Release 2 (PR2)

Interventions

Tapentadol ER Tamper-resistant Formulation (TRF) DRUG

Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.

Tapentadol ER PR2 then tapentadol ER TRF; Tapentadol Extended release (ER) TRF then tapentadol ER PR2

Tapentadol ER Prolonged-Release 2 (PR2) DRUG

Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.

Tapentadol ER PR2 then tapentadol ER TRF; Tapentadol Extended release (ER) TRF then tapentadol ER PR2

Eligibility Criteria

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

You may qualify if:

• Participants deemed healthy on the basis of pre-study 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
• Female participants must be post-menopausal, surgically sterile, or, if of childbearing potential/sexually active, be practicing an effective method of birth control throughout the study. Women must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on Day -1 of each treatment period. Men must not impregnate their partners
• Participants with body mass index (BMI) (weight \[kilogram {kg}\]/height \[meter {m}\^2\]) in-between 20 to 28 kg/m\^2, inclusive, and body weight not less than 50 kg
• Participants with blood pressure between 100 and 140 millimeters of mercury (mmHg) systolic, inclusive, and between 50 and 90 mmHg diastolic
• Participants who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the first study drug administration

You may not qualify if:

• Participants with 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 squealed suggesting transient changes in consciousness or symptoms
• Participants with 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, or any other illness that the Investigator considers should exclude the participants
• Participants who received an experimental drug or used an experimental medical device within 30 days or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled or to participate in an investigational drug study for at least 60 days after completion of the study
• Participants who have positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at Screening or Day -1 of each treatment period
• Participants who donated blood or blood products or had substantial loss of blood (greater than 500 milliliter) within 2 months before the first administration of study drug

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

Related Links

• A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet

Study Officials

• Johnson & Johnson Pharmaceutical R&D, L.L.C Clinical Trial

  Johnson & Johnson Pharmaceutical R&D, 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: July 12, 2013
• First Posted: July 16, 2013
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)