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Sponsors and Collaborators: |
Par Pharmaceutical, Inc. AAI Clinic |
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Information provided by: | Par Pharmaceutical, Inc. |
ClinicalTrials.gov Identifier: | NCT00652821 |
To compare the relative bioavailability of Kali and Ortho-McNeil's products
Condition | Intervention | Phase |
---|---|---|
To Determine Bioequivalence Under Fed Conditions. |
Drug: Tramadol/ APAP Drug: Ultracet |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fed Conditions. |
Enrollment: | 22 |
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 |
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A: Experimental
Subjects received Kali product under fed condition
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Drug: Tramadol/ APAP
Tablets 37.5mg /325mg
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B: Active Comparator
Subjects received Ortho-Mcneil product under fed conditions
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Drug: Ultracet
Tablets, 37.5mg/325mg
|
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:
Exclusion Criteria:
Responsible Party: | Par Pharmaceutical, Inc ( Alfred Elvin/ Director Biopharmaceutics ) |
Study ID Numbers: | AAI-US-122 |
Study First Received: | April 1, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00652821 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bioequivalence, single-dose, fed |
Malnutrition Analgesics, Non-Narcotic Tramadol Central Nervous System Depressants Nutrition Disorders |
Narcotics Peripheral Nervous System Agents Analgesics Analgesics, Opioid Acetaminophen |
Tramadol Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Malnutrition Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Nutrition Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Acetaminophen Analgesics, Opioid |