NCT00853294

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

An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Bioequivalence of an Extended Release Test Capsule Formulation of Chlorpheniramine Polistirex and Hydrocodone Polistirex Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in Normal Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule	Chlorpheniramine polistirex/hydrocodone polistirex extended release capsule, single dose fasting
DRUG	5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension	Tussionex® Pennkinetic® Extended Release Oral Suspension, single dose fasting

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2009-03-02
• Last updated: 2016-10-19