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

NCT00759902 | Completed Phase 1 Results

• 1 other identifier: 20-073-SA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

bioequivalence; 10 mg; KADIAN capsules; 20 mg; under fasted conditions

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs

Study Arms (2)

1

OTHER

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

Drug: morphine sulfate extended-release capsules; Drug: KADIAN (morphine sulfate extended-release) capsules

2

OTHER

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

Drug: morphine sulfate extended-release capsules; Drug: KADIAN (morphine sulfate extended-release) capsules

Interventions

morphine sulfate extended-release capsules DRUG

2 x 10 mg, single-dose capsule

Also known as: Treatment A, Test product

1; 2

KADIAN (morphine sulfate extended-release) capsules DRUG

1 x 20 mg, single-dose capsule

Also known as: Treatment B, Reference product

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

CEDRA Clinical Research, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Morphine; Capsules

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Meena Venugopal, Director, Clinical R&D
• Organization: Actavis Inc.

MVenugopal@actavis.com

908-659-2885

Study Officials

• James P. Doherty, DO

  CEDRA Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: August 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2006
• Last Updated: August 17, 2010
• Results First Posted: September 1, 2009

Record last verified: 2010-08

Locations

US (1)