A Pivotal Study to Evaluate the Bio-equivalence of the Ta... | NCT01900587

NCT01900587

ID	Type	Description	Link
R331333-PAI-1059

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time to Reach the Maximum Serum Concentration (T[max])	The T[max] is time to reach the observed maximum serum 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
Percentage of AUC(infinity)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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