NCT01880125

Brief Summary

  1. 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. 2.Subjects: Healthy subject
  3. 3.Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

June 13, 2013

Last Update Submit

April 29, 2021

Conditions

Pain

Keywords

TramadolAcetaminophenPharmacokineticsSustained releaseImmediate release

Outcome Measures

Primary Outcomes (2)

  • Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state

    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

    Bio-equivalence of AUC at steady state of tramadol and acetaminophen

    0 to 36 hour

Secondary Outcomes (7)

  • Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state

    0 to 36 hour

  • Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state

    0 to 36 hour

  • Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state

    0 to 36 hour

  • Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state

    0 to 36 hour

  • Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state

    0 to 36 hour

  • +2 more secondary outcomes

Study Arms (2)

Group A

OTHER

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

Group B

OTHER

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

Interventions

Tramadol HCI/AcetaminophenDRUG

Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.

Also known as: ULTRACET immediate release tablet, YJAT sustained release tablet
Group AGroup B

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Im YJ, Jeon JY, Kim EY, Kim Y, Oh DJ, Yoo JS, Shin DH, Chae SW, Kim MG. An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects. Clin Ther. 2015 Feb 1;37(2):376-89. doi: 10.1016/j.clinthera.2014.12.007. Epub 2015 Jan 22.

    PMID: 25618318DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ultracet

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 5, 2021

Record last verified: 2021-04