Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults

NCT ID: NCT00782548

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2004-06-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Test product A (1 x 30 mg KADIAN)

Group Type: ACTIVE_COMPARATOR

KADIAN (morphine sulfate sustained-release) capsules

Intervention Type: DRUG

Capsules, 30 mg

2

Reference product B (1 x 30 mg Avinza)

Group Type: ACTIVE_COMPARATOR

Avinza (morphine sulfate sustained-release) capsules

Intervention Type: DRUG

Capsules, 30 mg

Interventions

KADIAN (morphine sulfate sustained-release) capsules

Capsules, 30 mg

Intervention Type: DRUG

Avinza (morphine sulfate sustained-release) capsules

Capsules, 30 mg

Intervention Type: DRUG

Other Intervention Names

Test product A; Reference product B

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

MDS Pharma Services

Principal Investigators

Alan S. Marion, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

AA20003

Identifier Type: -

Identifier Source: org_study_id