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Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: To Determine Bioequivalence Under Fed Conditions.

Intervention: Tramadol/ APAP (Drug); Ultracet (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Ralph Scallion, Principal Investigator, Affiliation: AAI Clinic

Summary

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

Clinical Details

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

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

Primary outcome: Rate and Extent of Absorption

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: May 2002
Last updated: April 9, 2008

Page last updated: August 23, 2015

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