Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination
Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects
Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state
Subjects: Healthy subject
Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.
This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.
Period 1: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state
Period 1: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state
Inclusion Criteria: Subjects between the ages of 20 and 45 years Subjects weighed ≥ 45 kg and were within 20% of their ideal body weight No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test Exclusion Criteria: Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study Systolic blood pressure (SBP) ≥ 160 mmHg or ≤ 100 mmHg or diastolic blood pressure (DBP) ≥ 95 mmHg or ≤ 60 mmHg Any surgical or medical conditions that could affect drug absorption