Minimum age: 18 Years.
Maximum age: 45 Years.
- 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.
- 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
- Recent history (within one year) of mental illness, drug illness, drug abuse or
- 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
- 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
- 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.