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NCT00853190 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT00853190 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 43 participants.
The verdict
NCT00853190, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
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 fed conditions.
Interventions
- DRUG Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule
- DRUG 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2003-09 |
| Est. Completion | 2003-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853190
The ClinicalTrials.gov registry entry for NCT00853190 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule is the first listed.
NCT00853190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00853190 about?
NCT00853190 is a clinical study titled "Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension". 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 exten...
What is the current status of trial NCT00853190?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2003-09. Estimated completion is 2003-10.
What interventions are being tested in trial NCT00853190?
The interventions under investigation include: Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule (DRUG), 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension (DRUG).
Who is sponsoring clinical trial NCT00853190?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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