- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00782548
Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults
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
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- MDS Pharma Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- IUD in place for at least 3 months;
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
- surgical sterilization of the partner (vasectomy for 6 months minimum);
- 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:
- alcoholism or drug abuse within the past 2 years;
- asthma or other chronic respiratory illness;
- gastrointestinal dysmobility or recent enteritis;
- hypersensitivity or idiosyncratic reaction to morphine or other opioids;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Test product A (1 x 30 mg KADIAN)
|
Capsules, 30 mg
Other Names:
|
Active Comparator: 2
Reference product B (1 x 30 mg Avinza)
|
Capsules, 30 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide
Time Frame: 60 hours post-dose
|
60 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
monitored throughout study, until resolution
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan S. Marion, MD, PhD, MDS Pharma Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA20003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on KADIAN (morphine sulfate sustained-release) capsules
-
Actavis Inc.Completed
-
Actavis Inc.Completed
-
Actavis Inc.Completed
-
Actavis Inc.CompletedHealthyUnited States
-
Actavis Inc.Completed
-
Actavis Inc.Completed
-
Stanford UniversityTerminated
-
University Health Network, TorontoCanadian Society of Hospital PharmacistsWithdrawn
-
Sun Yat-sen UniversityCompleted
-
Brigham and Women's HospitalNational Institute on Drug Abuse (NIDA); Arthritis FoundationCompletedDepression | Anxiety | Degenerative Disc Disease | Chronic Low Back PainUnited States