Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

This study has been completed.
AAI Clinic
Information provided by:
Par Pharmaceutical, Inc. Identifier:
First received: April 1, 2008
Last updated: April 9, 2008
Last verified: April 2008
To compare the relative bioavailability of Kali and Ortho-McNeil's

Condition Intervention Phase
To Determine Bioequivalence Under Fasting Conditions
Drug: Tramadol APAP
Drug: Ultracet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Rate and Extend of absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00653315

Sponsors and Collaborators
Par Pharmaceutical, Inc.
AAI Clinic
Principal Investigator: Ralph Scallion AAI Clinic
  More Information

Responsible Party: Alfred Elvin// Director Biopharmaceutics, Par Pharmaceutical, Inc. Identifier: NCT00653315     History of Changes
Other Study ID Numbers: AAI-US-121 
Study First Received: April 1, 2008
Last Updated: April 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
Bioequivalence, Tramadol APAP, fasting

Additional relevant MeSH terms:
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016