HealthyPhase 4NCT00782548
Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults
A Phase 4 study testing KADIAN (morphine sulfate sustained-release) capsules and Avinza (morphine sulfate sustained-release) capsules in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KADIAN (morphine sulfate sustained-release) capsules and Avinza (morphine sulfate sustained-release) capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jun 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- KADIAN (morphine sulfate sustained-release) capsules, Avinza (morphine sulfate sustained-release) capsules
- Keywords
- KADIAN, morphine, Avinza, 30 mg, bioequivalence, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KADIAN (morphine sulfate sustained-release) capsulesDrug
Also called Test product A
Capsules, 30 mg
Avinza (morphine sulfate sustained-release) capsulesDrug
Also called Reference product B
Capsules, 30 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Test product A (1 x 30 mg KADIAN) Receives: Drug: KADIAN (morphine sulfate sustained-release) capsules |
| 2 | Active comparator | Reference product B (1 x 30 mg Avinza) Receives: Drug: Avinza (morphine sulfate sustained-release) capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide
Measured: 60 hours post-dose
Secondary outcomes (1)
To evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations
Measured: monitored throughout study, until resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startMay 2004
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan S. Marion, MD, PhD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782548
- Sponsor's protocol ID
- AA20003
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2008
- Last updated
- 16 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00782548
- Acronym / sponsor ID
- AA20003
- Conditions
- Healthy
- Keywords
- KADIAN, morphine, Avinza, 30 mg, bioequivalence, fed
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: KADIAN (morphine sulfate sustained-release) capsulesTest product A (1 x 30 mg KADIAN) |
| 2 | Active comparator | Drug: Avinza (morphine sulfate sustained-release) capsulesReference product B (1 x 30 mg Avinza) |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- Other birth control methods may have been deemed acceptable. Postmenopausal women with amenorrhea for > than 2 year, and confirmed by blood testing.
Key exclusion criteria (16 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KADIAN (morphine sulfate sustained-release) capsulesAlso: Test product ACapsules, 30 mg | Drug | 1 |
| Avinza (morphine sulfate sustained-release) capsulesAlso: Reference product BCapsules, 30 mg | Drug | 2 |
Primary outcome
Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide
Time frame: 60 hours post-dose
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan S. Marion, MD, PhD principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing KADIAN (morphine sulfate sustained-release) capsules and Avinza (morphine sulfate sustained-release) capsules in people with Healthy, run by Actavis Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide (time frame: 60 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.