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CompletedNCT00653315Updated Apr 11, 2008

Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

A Phase 1 interventional study of Tramadol APAP and Ultracet in To Determine Bioequivalence Under Fasting Conditions, sponsored by Par Pharmaceutical, Inc.. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-11.

Sponsored by Par Pharmaceutical, Inc. (part of Par Health) · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • To Determine Bioequivalence Under Fasting Conditions

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Keywords

  • Bioequivalence, Tramadol APAP, fasting
03

In context

Fasting

86 studies on the registry are indexed under Fasting; 38 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 66 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Par Pharmaceutical, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

First submitted before Par Pharmaceutical, Inc. became part of Par Health.

Browse Par Pharmaceutical, Inc. studies →All Par Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    A

    Subjects received kali product under fasting conditions

    Drug: Tramadol APAP

  • Active comparator
    B

    Subjects received Ortho-Mcneil product under fasting conditions

    Drug: Ultracet

Interventions

  • DrugTramadol APAP

    Tablets, 37.5mg/325mg, single dose

    Also known as: Ultracet

  • DrugUltracet

    Tablets, 37.5mg/325mg

    Also known as: Tramadol APAP

06

What researchers measure

Primary outcomes

  1. Rate and Extend of absorption

    Time frame: 24 Hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00653315
Lead sponsor
Par Pharmaceutical, Inc.
Collaborators
AAI Clinic
First posted
Apr 4, 2008
Start date
May 2002
Primary completion
Aug 2002
Completion
Aug 2002
Last update
Apr 11, 2008

Study contacts

Ralph Scallion
principal investigator · AAI Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ultracet

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