Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00782548

Recruitment Status : Completed

First Posted : October 31, 2008

Last Update Posted : October 31, 2008

Sponsor:

Information provided by:

Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Study Description

Brief Summary:

The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30 mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed conditions.

The secondary objective of this study was to evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: morphine sulfate sustained-release capsules	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	A Phase IV, Comparative, Randomized, Double Blind, Single-Dose, 2-Way Crossover Study to Evaluate the Pharmacokinetics and Safety of Alpharma Branded Products Division (KADIAN)and Ligand Pharmaceuticals Inc. (Avinza) 30 mg Morphine Sulfate Sustained-Release Capsules in Healthy Adult Volunteers Under Fed Conditions
Study Start Date :	May 2004
Actual Primary Completion Date :	June 2004
Actual Study Completion Date :	June 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Morphine sulfate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Test product A (1 x 30 mg KADIAN)	Drug: morphine sulfate sustained-release capsules Capsules, 30 mg
Active Comparator: 2 Test product B (1 x 30 mg Avinza)	Drug: morphine sulfate sustained-release capsules Capsules, 30 mg

Outcome Measures

Primary Outcome Measures :

Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide [ Time Frame: 60 hours post-dose ]

Secondary Outcome Measures :

To evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations [ Time Frame: monitored throughout study, until resolution ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	19 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy adult non-smoker, or moderate smokers (less than 10 cigarettes per day for at least 3 months) or ex-smoker (no smoking for at least 3 months) male or female volunteers, 19 to 40 years of age.
Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
Medically healthy subjects with no clinically significant abnormalities in their laboratory profile and ECGs, as deemed by the Principal Investigator.
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
1. surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
2. IUD in place for at least 3 months;
3. barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
4. surgical sterilization of the partner (vasectomy for 6 months minimum);
5. hormonal contraceptives for at least 3 months prior to the first dose of the study.

Other birth control methods may have been deemed acceptable. Postmenopausal women with amenorrhea for > than 2 year, and confirmed by blood testing.

Voluntarily consent to participate in the study.

Exclusion criteria:

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, history or presence of:
1. alcoholism or drug abuse within the past 2 years;
2. asthma or other chronic respiratory illness;
3. gastrointestinal dysmobility or recent enteritis;
4. hypersensitivity or idiosyncratic reaction to morphine or other opioids;
5. hypersensitivity or idiosyncratic reaction to naltrexone, naloxone, or other narcotic antagonists.
Female subjects who were pregnant or lactating.
Subjects who had a surgery of the gastrointestinal tract (except appendectomy) which would interfere with absorption of the study drug
Subjects who received hepatic enzyme inducing drugs (e.g. Nizoral®, Tagamet®) within the previous three months
Subjects whose sitting blood pressure was less than 110/60 mm Hg at screening or 100/55 mm Hg before dosing.
Subjects who were on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
Subjects who had made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the study.
Subjects who had made a plasma donation within 7 days prior to the study.
Subjects with hemoglobin less than 12.0 g/dL.
Subjects who had participated in another clinical trial within 28 days prior to the first dose.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782548

Locations


United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Investigators


Principal Investigator:	Alan S. Marion, MD, PhD	MDS Pharma Services

More Information


Responsible Party:	Alan S. Marion, MD, PhD, MDS Pharma Services
ClinicalTrials.gov Identifier:	NCT00782548 History of Changes
Other Study ID Numbers:	AA20003
First Posted:	October 31, 2008 Key Record Dates
Last Update Posted:	October 31, 2008
Last Verified:	October 2008

Keywords provided by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.:


KADIAN morphine Avinza	30 mg bioequivalence fed

Additional relevant MeSH terms:


Morphine Analgesics, Opioid Narcotics Central Nervous System Depressants	Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

To Top