drugset
drugset / Trial / NCT00853294

Fasting Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension

NCT00853294 ↗

Phase 1 Completed 42 enrolled Mallinckrodt
RandomizedCrossoverOpen-label

Summary

The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a commercially available extended release oral suspension of chlorpheniramine polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fasting conditions.

Timeline

Start
2003-09
Primary completion
2003-09
Completion
2003-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorpheniramine Unknown 8 mg Oral
Comparator Hydrocodone Unknown 10 mg Oral

Indications

No indication recorded.