Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Par Pharmaceutical, Inc.
• Collaborator: AAI Clinic
• Treatments: Acetaminophen; Tramadol

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.