Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions (NCT00652821) | Clinical Trial Compass
CompletedPhase 1
Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions
22 participantsStarted 2002-05
Plain-language summary
To compare the relative bioavailability of Kali and Ortho-McNeil's products
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…