Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

• ClinicalTrials.gov Identifier: NCT00653315
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Last Update Posted: April 11, 2008
• Sponsor: Par Pharmaceutical, Inc.
• Collaborator: AAI Clinic
• Information provided by: Par Pharmaceutical, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
To Determine Bioequivalence Under Fasting Conditions	Drug: Tramadol APAP; Drug: Ultracet	Phase 1

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.
• Study Start Date: May 2002
• Actual Primary Completion Date: August 2002
• Actual Study Completion Date: August 2002

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Subjects received kali product under fasting conditions	Drug: Tramadol APAP; Tablets, 37.5mg/325mg, single dose; Other Name: Ultracet
Active Comparator: B; Subjects received Ortho-Mcneil product under fasting conditions	Drug: Ultracet; Tablets, 37.5mg/325mg; Other Name: Tramadol APAP

Outcome Measures

Primary Outcome Measures :

1. Rate and Extend of absorption [ Time Frame: 24 Hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

Par Pharmaceutical, Inc.

AAI Clinic

Investigators

• Principal Investigator: Ralph Scallion; AAI Clinic

More Information

• Responsible Party: Alfred Elvin// Director Biopharmaceutics, Par Pharmaceutical, Inc.
• ClinicalTrials.gov Identifier: NCT00653315 History of Changes
• Other Study ID Numbers: AAI-US-121
• First Posted: April 4, 2008
• Last Update Posted: April 11, 2008
• Last Verified: April 2008

Keywords provided by Par Pharmaceutical, Inc.:

Bioequivalence, Tramadol APAP, fasting

Additional relevant MeSH terms:

Disease; Pathologic Processes; Acetaminophen; Tramadol; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Non-Narcotic; Antipyretics