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Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions

Primary Purpose

To Determine Bioequivalence Under Fed Conditions

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tramadol/ APAP
Ultracet
Sponsored by
Par Pharmaceutical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for To Determine Bioequivalence Under Fed Conditions focused on measuring bioequivalence, single-dose, fed

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Males and females between 18 and 45 years of age inclusive
  • Informed of the nature of the study and given written informed consent.
  • Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.

Exclusion Criteria:

  • Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
  • Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
  • Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
  • Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
  • Received an investigational drug within the 4 weeks prior to study dosing.
  • Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
  • This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
  • Tobacco use(>5 cigarettes per day)in the 3 months prior to study dosing.
  • If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
  • Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
  • Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
  • females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    Subjects received Kali product under fed condition

    Subjects received Ortho-Mcneil product under fed conditions

    Outcomes

    Primary Outcome Measures

    Rate and Extent of Absorption

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    September 22, 2017
    Sponsor
    Par Pharmaceutical, Inc.
    Collaborators
    AAI Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00652821
    Brief Title
    Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
    Official Title
    To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fed Conditions.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    August 2002 (Actual)
    Study Completion Date
    August 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Par Pharmaceutical, Inc.
    Collaborators
    AAI Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare the relative bioavailability of Kali and Ortho-McNeil's products
    Detailed Description
    To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    To Determine Bioequivalence Under Fed Conditions
    Keywords
    bioequivalence, single-dose, fed

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Subjects received Kali product under fed condition
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    Subjects received Ortho-Mcneil product under fed conditions
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol/ APAP
    Other Intervention Name(s)
    Ultracet
    Intervention Description
    Tablets 37.5mg /325mg
    Intervention Type
    Drug
    Intervention Name(s)
    Ultracet
    Other Intervention Name(s)
    Tramadol/APAP
    Intervention Description
    Tablets, 37.5mg/325mg
    Primary Outcome Measure Information:
    Title
    Rate and Extent of Absorption
    Time Frame
    24 Hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy Males and females between 18 and 45 years of age inclusive Informed of the nature of the study and given written informed consent. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs. Exclusion Criteria: Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures. Any history of a clinical condition which might affect drug absorption, metabolism or excretion. Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism. Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. Received an investigational drug within the 4 weeks prior to study dosing. Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician. Tobacco use(>5 cigarettes per day)in the 3 months prior to study dosing. If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ralph Scallion
    Organizational Affiliation
    AAI Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions

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