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Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00653315
First Posted: April 4, 2008
Last Update Posted: April 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AAI Clinic
Information provided by:
Par Pharmaceutical, Inc.
  Purpose
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
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.

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 ]

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
  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653315


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 Submitted: April 1, 2008
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
Tramadol
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics