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Trial record 13 of 456 for:    TRAMADOL

Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination

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ClinicalTrials.gov Identifier: NCT01880125
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : June 18, 2013
Sponsor:
Collaborator:
Chonbuk National University Hospital
Information provided by (Responsible Party):
Yungjin Pharm. Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Tramadol HCI/Acetaminophen Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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 Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other Names:
  • ULTRACET immediate release tablet
  • YJAT sustained release tablet

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
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.
Other Names:
  • ULTRACET immediate release tablet
  • YJAT sustained release tablet




Primary Outcome Measures :
  1. Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state [ Time Frame: 0 to 36 hour ]
    Bio-equivalence of Cmax and AUC at steady state of tramadol and acetaminophen


Secondary Outcome Measures :
  1. Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state [ Time Frame: 0 to 36 hour ]

    Tmax, Half-life, Accumulation index of tramadol and acetaminophen at steady state.

    Cmax, AUC, Tmax, Half-life of O-desmethyltramadol at steady state




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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yungjin Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01880125     History of Changes
Other Study ID Numbers: YJ4-101
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Yungjin Pharm. Co., Ltd.:
Tramadol
Acetaminophen
Pharmacokinetics
Sustained release
Immediate release
Additional relevant MeSH terms:
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Tramadol
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants