Other Clinical Trial - Bioavailability Study of Tramadol/APAP Tablets

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Status Completed

Clinical Trial Summary

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 ;

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

See also
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Completed	`NCT00653419` - Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions	Phase 1
Completed	`NCT00652795` - Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions	Phase 1
Completed	`NCT01380457` - Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions	Phase 1
Completed	`NCT01380483` - Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions	Phase 1
Completed	`NCT00652639` - Bioavailability Study of Clonazepam Tablets Under Fasting Conditions	Phase 1
Completed	`NCT00653055` - Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions	Phase 1
Completed	`NCT00653549` - Bioavailability Study of Torsemide Tablets Under Fasting Conditions	Phase 1