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

April 29, 2021 updated by: Yungjin Pharm. Co., Ltd.

Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 to 36 hour
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
0 to 36 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 to 36 hour
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.
0 to 36 hour
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.
0 to 36 hour
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
0 to 36 hour
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
0 to 36 hour
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
0 to 36 hour
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
0 to 36 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yungjin Pharm. Co., Ltd.

Collaborators

Chonbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJ4-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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