Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination
Overview
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.
Full Title of Study: “Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: May 2012
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
- Drug: Tramadol HCI/Acetaminophen
- Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.
Arms, Groups and Cohorts
- Other: Group A
- 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
- Other: Group B
- 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
Clinical Trial Outcome Measures
Primary Measures
- Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
- Time Frame: 0 to 36 hour
- Bio-equivalence of Cmax at steady state of tramadol and acetaminophen
- Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
- Time Frame: 0 to 36 hour
- Bio-equivalence of AUC at steady state of tramadol and acetaminophen
Secondary Measures
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- Tmax of tramadol and acetaminophen at steady state.
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- Half-life of tramadol and acetaminophen at steady state.
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- Accumulation index of tramadol and acetaminophen at steady state.
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- Cmax of O-desmethyltramadol at steady state
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- AUC of O-desmethyltramadol at steady state
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- Tmax of O-desmethyltramadol at steady state
- Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
- Time Frame: 0 to 36 hour
- Half-life of O-desmethyltramadol at steady state
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Yungjin Pharm. Co., Ltd.
- Collaborator
- Chonbuk National University Hospital
- Provider of Information About this Clinical Study
- Sponsor
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