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Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
This study has been completed.
Study NCT00652821   Information provided by Par Pharmaceutical, Inc.
First Received: April 1, 2008   Last Updated: April 9, 2008   History of Changes

April 1, 2008
April 9, 2008
May 2002
August 2002   (final data collection date for primary outcome measure)
Rate and Extent of Absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652821 on ClinicalTrials.gov Archive Site
 
 
 
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fed Conditions.

To compare the relative bioavailability of Kali and Ortho-McNeil's products

To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg

Phase I
Interventional
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
To Determine Bioequivalence Under Fed Conditions.
  • Drug: Tramadol/ APAP
    Tablets 37.5mg /325mg
    Other Name: Ultracet
  • Drug: Ultracet
    Tablets, 37.5mg/325mg
    Other Name: Tramadol/APAP
  • A: Experimental
    Subjects received Kali product under fed condition
    Intervention: Drug: Tramadol/ APAP
  • B: Active Comparator
    Subjects received Ortho-Mcneil product under fed conditions
    Intervention: Drug: Ultracet
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
22
August 2002
August 2002   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00652821
Alfred Elvin/ Director Biopharmaceutics, Par Pharmaceutical, Inc
AAI-US-122
Par Pharmaceutical, Inc.
AAI Clinic
Principal Investigator: Ralph Scallion AAI Clinic
Par Pharmaceutical, Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP