A Randomized Two-way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Formulation of KADIAN (2 x 10mg) Capsules Compared to a KADIAN 20 mg Capsule in Healthy Adult Subjects Under Fed Conditions

Actavis Inc.1 site in 1 country36 target enrollmentAugust 2006

ConditionsHealthy

Interventionsmorphine sulfate extended-release capsules KADIAN (morphine sulfate extended-release) capsules

Drugsmorphine sulfate extended-release capsules KADIAN (morphine sulfate extended-release) capsules

Overview

Phase: Phase 1
Intervention: morphine sulfate extended-release capsules
Conditions: Healthy
Sponsor: Actavis Inc.
Enrollment: 36
Locations: 1
Primary Endpoint: Maximum Plasma Morphine Concentration
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma Branded Products Inc.. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

October 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Actavis Inc.

Eligibility Criteria

Inclusion Criteria

•Subject must be a male or non-pregnant, non-breast-feeding female.
•Subject must be between 18 and 55 years of age (inclusive).
•Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
•Female subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, at least from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection) in use at least 3 consecutive months prior to first dose of study medication, double barrier (condom with spermicide and diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
•Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
•Subject is willing and able to consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required during each study period.
•Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for all outpatient visits.

Exclusion Criteria

•History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
•Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
•History or presence of allergic or adverse response to the study drug or related drugs.
•Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
•Has donated blood or plasma within 30 days prior to the first dose of study medication.
•Has participated in another clinical trial within 30 days prior to first dose of study medication.
•Has used any over-the-counter (OTC) medication including nutritional supplements, within 7 days prior to the first dose of study medication.
•Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
•Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
•Has smoked or used tobacco products within 60 days prior to the first dose of study medication.

Arms & Interventions

1

Treatment A (test product) followed by Treatment B (reference product)

Intervention: morphine sulfate extended-release capsules

1

Treatment A (test product) followed by Treatment B (reference product)

Intervention: KADIAN (morphine sulfate extended-release) capsules

2

Treatment B (reference product) followed by Treatment A (test product)

Intervention: morphine sulfate extended-release capsules

2

Treatment B (reference product) followed by Treatment A (test product)

Intervention: KADIAN (morphine sulfate extended-release) capsules

Outcomes

Primary Outcomes

Maximum Plasma Morphine Concentration

Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs

Secondary Outcomes

Time of Maximum Plasma Morphine Concentration(0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs)
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine(0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs)
Area Under the Curve to Infinity for Plasma Morphine(0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs)