| April 1, 2008 |
| April 9, 2008 |
| May 2002 |
| August 2002 (final data collection date for primary outcome measure) |
| Rate and Extend of absorption [ Time Frame: 24 Hours ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00653315 on ClinicalTrials.gov Archive Site |
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| Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions |
| To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions. |
To compare the relative bioavailability of Kali and Ortho-McNeil's |
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg |
| Phase I |
| Interventional |
| Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| To Determine Bioequivalence Under Fasting Conditions |
- Drug: Tramadol APAP
- Drug: Ultracet
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- Experimental: Subjects received kali product under fasting conditions
- Active Comparator: Subjects received Ortho-Mcneil product under fasting conditions
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| Completed |
| 28 |
| August 2002 |
| August 2002 (final data collection date for primary outcome measure) |
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.
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| Both |
| 18 Years to 45 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00653315 |
| Alfred Elvin// Director Biopharmaceutics, Par Pharmaceutical, Inc. |
| AAI-US-121 |
| Par Pharmaceutical, Inc. |
| AAI Clinic |
| Principal Investigator: |
Ralph Scallion |
AAI Clinic |
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| Par Pharmaceutical, Inc. |
| April 2008 |