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

NCT00853294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-10-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Herbert Neuman, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2003-09-30
Completion
2003-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853294 on ClinicalTrials.gov