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.
Full Title of Study: “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 Fed Conditions”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2003
- 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 with food
- 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 with food
Arms, Groups and Cohorts
- Experimental: A
- Chlorpheniramine polistirex/hydrocodone polistirex extended release capsule
- Active Comparator: B
- Tussionex® Pennkinetic® Extended Release Oral Suspension
Clinical Trial Outcome Measures
- Bioequivalence based on AUCf, AUCinf and Cmax
- Time Frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 72 hours. Washout period between doses was 7 days.
Participating in This Clinical Trial
1. Males or non-pregnant, non-lactating females, 18 years of age or older.
2. Female subjects must be postmenopausal for at least one year, or surgically sterile, or practicing adequate non-hormonal contraception for at least 3 months prior to and for the duration of study participation. All female subjects will undergo a pregnancy test at screening and at check-in to the clinical study site for every dosing period. The results of the test must be negative for continued participation.
3. Weight must be within 15% of the ideal weight for height and frame, as adopted by the Metropolitan Life Insurance Co., 1993.
4. Qualifying subjects must be in good health and physical condition as determined by a screening medical history obtained within 30 days prior to study start. Subjects should not present with a history of significant past illness expected to affect the investigation.
5. The normal status of subjects will be confirmed by the following procedures:
1. Laboratory tests (chemistry, hematology, urinalysis)
2. Human immunodeficiency virus (HIV), hepatitis, alcohol, and "drugs of abuse" testing will be done for screening purposes only. Results of the HIV, hepatitis, and "drugs of abuse" tests must be negative or non-reactive for subjects to qualify for the study.
3. Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. This ECG must be interpreted by appropriately trained and experienced medical personnel. A subject with an ECG that is not within normal range does not qualify, unless specifically accepted (with comment) by the investigator.
6. Subjects must be able to provide written consent and agree to abide by the study requirements (including consuming the entire standardized breakfast).
1. History of chronic alcohol, drug, or narcotic abuse.
2. Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
3. History or presence of major organ dysfunction.
4. History of malignancy, stroke, or diabetes; cardiac, renal, liver, pulmonary, or severe gastrointestinal disease; or other serious illness.
5. History of anxiety, tension, severe agitation, psychosis, or mental depression.
6. Family history or diagnosis of epilepsy or other seizure disorder.
7. History of glaucoma.
8. History of acute abdominal conditions.
9. History of conditions which might contraindicate or require caution be used in the administration of chlorpheniramine/hydrocodone, including: history of renal impairment, hepatic or biliary tract disease, inflammatory bowel disease, ulcerative colitis, constipation, diarrhea, gastrointestinal obstruction or ileus, cardiac disease, hypertension, bladder obstruction, pain or difficulty passing urine, systemic lupus erythematosus, head trauma, increased intracranial pressure, pulmonary disease, asthma, or history of hypersensitivity to any opiate agonists or antihistamines.
10. Administration of any other investigational drug during the 30 days prior to enrollment into the study.
11. Subjects who smoke or have a history of smoking, or use nicotine-containing products.
12. Subjects who have donated blood within 30 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
13. Subjects presenting with acute illness.
14. Subjects who must wear contact lenses during the study.
15. Subjects who have taken prescription drugs within 14 days or over-the-counter medications (including herbal preparations) within 7 days prior to dosing except for standard daily dose multivitamins.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Provider of Information About this Clinical Study
- Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt
- Overall Official(s)
- Herbert Neuman, MD, Study Director, Mallinckrodt
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