Pain
Conditions
Keywords
Tramadol, Acetaminophen, Pharmacokinetics, Sustained release, Immediate release
Brief summary
1. 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 2. Subjects: Healthy subject 3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.
Detailed description
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.
Interventions
Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.
Sponsors
Chonbuk National University Hospital
Yungjin Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state | 0 to 36 hour | Bio-equivalence of Cmax at steady state of tramadol and acetaminophen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state | 0 to 36 hour | Tmax of tramadol and acetaminophen at steady state. |
Outcome results
None listed