Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

NCT00653315 | Completed Phase 1

• 1 other identifier: AAI-US-121
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

Bioequivalence, Tramadol APAP, fasting

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of absorption

  24 Hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received kali product under fasting conditions

Drug: Tramadol APAP

B

ACTIVE COMPARATOR

Subjects received Ortho-Mcneil product under fasting conditions

Drug: Ultracet

Interventions

Tramadol APAP DRUG

Tablets, 37.5mg/325mg, single dose

Also known as: Ultracet

A

Ultracet DRUG

Tablets, 37.5mg/325mg

Also known as: Tramadol APAP

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• AAI Clinic: collaborator

MeSH Terms

Conditions

Fasting

Interventions

Ultracet

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Ralph Scallion

  AAI Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: May 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: April 11, 2008

Record last verified: 2008-04