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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: | NCT00653315 |
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 I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, 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 Fasting Conditions. |
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 |
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A: Experimental
Subjects received kali product under fasting conditions
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Drug: Tramadol APAP
Tablets, 37.5mg/325mg, single dose
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B: Active Comparator
Subjects received Ortho-Mcneil product under fasting 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-121 |
Study First Received: | April 1, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00653315 |
Health Authority: | United States: Food and Drug Administration |
Bioequivalence, Tramadol APAP, fasting |
Tramadol Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |