Clinical trial NCT00653315: Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
Official title: To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine Bioequivalence Under Fasting Conditions
Keywords: Bioequivalence, Tramadol APAP, fasting
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AAI Clinic
First posted: 2008-04-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

Eligibility 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.

Primary outcomes:
measure: Rate and Extend of absorption
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AAI Clinic
name: Ralph Scallion
role: PRINCIPAL_INVESTIGATOR
References: