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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