Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

Official title:

To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653315
• Other study ID #: AAI-US-121
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: April 9, 2008
• Start date: May 2002
• Est. completion date: August 2002

Study information

• Verified date: April 2008
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• To Determine Bioequivalence Under Fasting Conditions

Intervention

Drug:
• Tramadol APAP
Tablets, 37.5mg/325mg, single dose
• Ultracet
Tablets, 37.5mg/325mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	AAI Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and Extend of absorption		24 Hours	No