Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions

NCT ID: NCT00759902

Last Updated: 2010-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2006-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: OTHER

morphine sulfate extended-release capsules

Intervention Type: DRUG

2 x 10 mg, single-dose capsule

KADIAN (morphine sulfate extended-release) capsules

Intervention Type: DRUG

1 x 20 mg, single-dose capsule

2

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

Group Type: OTHER

morphine sulfate extended-release capsules

Intervention Type: DRUG

2 x 10 mg, single-dose capsule

KADIAN (morphine sulfate extended-release) capsules

Intervention Type: DRUG

1 x 20 mg, single-dose capsule

Interventions

morphine sulfate extended-release capsules

2 x 10 mg, single-dose capsule

Intervention Type: DRUG

KADIAN (morphine sulfate extended-release) capsules

1 x 20 mg, single-dose capsule

Intervention Type: DRUG

Other Intervention Names

Treatment A; Test product; Treatment B; Reference product

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 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 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 KADIAN 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.
• Has a history of treatment for substance abuse (including alcohol) in the past 5 years.
• Is a female with a positive pregnancy test result.
• Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
• Has had a positive test for, or has been treated for Hepatitis B, Hepatitis C or HIV.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

James P. Doherty, DO

Role: PRINCIPAL_INVESTIGATOR

CEDRA Clinical Research, LLC

Locations

CEDRA Clinical Research, LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

20-073-SA

Identifier Type: -

Identifier Source: org_study_id