Clinical trial NCT02019485: A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects
Official title: A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess Bioequivalence of a New Tapentadol Extended-Release (TRF) 100-mg Tablet With Respect to a Tapentadol Extended-Release (PR2) 100-mg Tablet Under Fasted Conditions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Tapentadol
Tapentadol extended-release tamper-resistant formulation
Tapentadol extended-release prolonged-release formulation
Bioequivalence
Fasted Conditions
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2013-12-24
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate bioequivalence (biological equivalence of two formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg, prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted (without food) conditions.

Detailed description: This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study), single-dose, and single-center study. The study consists of 3 phases: the screening phase, treatment phase, and end-of-study or withdrawal assessment phase. In the treatment phase, participants will receive a single dose of new tapentadol ER 100-mg TRF tablet (Treatment A) and current tapentadol ER 100-mg PR2 (Treatment B) under fasted conditions in 2 treatment sequences (AB and BA). Administration of the study medication will be separated by a washout period (no treatment) of 7 to14 days. Approximately 64 participants will be enrolled in this study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The duration of participation in the study for an individual participant will be approximately 5.5 weeks.

Eligibility criteria: Inclusion Criteria:

* Agrees to protocol-defined use of effective contraception
* Body mass index (BMI) between 20 and 28 kilograms per square meter, inclusive, and body weight not less than 50 kg (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])
* Habitually 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 medication administration

Exclusion Criteria:

* History of seizure disorder or epilepsy or mild or severe traumatic brain injury
* Men with hemoglobin concentrations below 12.5 g/dL or women with hemoglobin concentrations below 11.5 g/dL
* 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
* Positive test for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies
* History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness

Primary outcomes:
measure: Maximum serum concentration of tapentadol
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication)
measure: Time to reach the observed maximum serum concentration of tapentadol
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: Area under the serum concentration-time curve of tapentadol from time 0 to the time of the last quantifiable concentration
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: Area under the serum concentration-time curve of tapentadol from time 0 to infinite time
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: Percentage of area under the serum concentration-time curve of tapentadol from time 0 to infinite time
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: Elimination half-life associated with the terminal slope of the semilogarithmic tapentadol concentration-time curve
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: First-order rate constant associated with the terminal portion of tapentadol concentration curve
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: Time to last quantifiable serum concentration of tapentadol
timeFrame: Predose; 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose (at each single-dose of study medication
measure: Number of participants with adverse events
timeFrame: Up to end-of-study (Day 3 of last single-dose of study medication)
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: