Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
Phase 1
Completed
- Conditions
- To Determine Bioequivalence Under Fasting Conditions
- Interventions
- Registration Number
- NCT00653315
- Lead Sponsor
- Par Pharmaceutical, Inc.
- Brief Summary
To compare the relative bioavailability of Kali and Ortho-McNeil's
- Detailed Description
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Tramadol APAP Subjects received kali product under fasting conditions B Ultracet Subjects received Ortho-Mcneil product under fasting conditions
- Primary Outcome Measures
Name Time Method Rate and Extend of absorption 24 Hours
- Secondary Outcome Measures
Name Time Method