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
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

No publications provided

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:
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Analgesics, Opioid processed this record on April 23, 2014