Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00653315 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : April 11, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
To Determine Bioequivalence Under Fasting Conditions | Drug: Tramadol APAP Drug: Ultracet | Phase 1 |
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 |

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 |
- Rate and Extend of absorption [ Time Frame: 24 Hours ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
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.

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
Principal Investigator: | Ralph Scallion | AAI Clinic |
Responsible Party: | Alfred Elvin// Director Biopharmaceutics, Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00653315 |
Other Study ID Numbers: |
AAI-US-121 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | April 11, 2008 |
Last Verified: | April 2008 |
Bioequivalence, Tramadol APAP, fasting |
Disease Pathologic Processes Tramadol Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |