HealthyPhase 1NCT00759954
Comparison of One Morphine Sulfate Sustained-Release 200 mg Capsule With Two 100 mg KADIAN Capsules on Applesauce
A Phase 1 study testing morphine sulfate sustained-release capsules and KADIAN (morphine sulfate sustained-release) capsules in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- morphine sulfate sustained-release capsules and KADIAN (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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be a male or non-pregnant, non-breast-feeding female.
- Subject must be between 18 and 50 years of age inclusive.
- Subject's body weight should be within +/- 15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table and 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, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
- 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 any outpatient visits.
Who cannot join
- 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 or clinical laboratory results at screening.
- History or presence of allergic or adverse response to the study drug 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.
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- Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.
- Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication without evaluation and approval by the study investigator.
- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Administered Orally as a Sprinkle on Applesauce
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered as a sprinkle on applesauce after a 10-hour overnight fast.
- Conditions
- Healthy
- Being tested
- morphine sulfate sustained-release capsules, KADIAN (morphine sulfate sustained-release) capsules
- Keywords
- bioequivalence, morphine sulfate sustained release capsules, KADIAN capsules, 200 mg, applesauce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine sulfate sustained-release capsulesDrug
Also called Treatment A, Test product
1 x 200 mg, single-dose capsule
KADIAN (morphine sulfate sustained-release) capsulesDrug
Also called Treatment B, Reference product
2 x 100 mg, single-dose capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Treatment A (test product) followed by Treatment B (reference product) Receives: Drug: morphine sulfate sustained-release capsules; Drug: KADIAN (morphine sulfate sustained-release) capsules |
| 2 | Other | Treatment B (reference product) followed by Treatment A (test product) Receives: Drug: morphine sulfate sustained-release capsules; Drug: KADIAN (morphine sulfate sustained-release) capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Morphine Concentration
calculated from drug concentration over time
Measured: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
Secondary outcomes (3)
Time of Maximum Plasma Morphine Concentration
calculated from drug concentration over time
Measured: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
calculated from drug concentration over time
Measured: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
Area Under the Curve to Infinity for Plasma Morphine
Measured: 0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2004
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel V. Freeland, DO, Principal investigator, CEDRA Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759954
- Sponsor's protocol ID
- 20-701-1N
- Status last verified
- Aug 2010
- First submitted
- 24 Sep 2008
- Last updated
- 17 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study Comparing the Bioavailability of a Morphine Sulfate Sustained Release Capsule 1 x 200mg to KADIAN 2 x 100mg Capsules Administered Orally as a Sprinkle on Applesauce
- ClinicalTrials.gov ID
- NCT00759954
- Acronym / sponsor ID
- 20-701-1N
- Conditions
- Healthy
- Keywords
- bioequivalence, morphine sulfate sustained release capsules, KADIAN capsules, 200 mg, applesauce
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 1 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules manufactured by Alpharma Branded Products Division Inc. to an equivalent oral dose of the commercially available reference product, KADIAN 2 x 100 mg capsules manufactured by Alpharma Branded Products Division Inc. when administered as a sprinkle on applesauce after a 10-hour overnight fast.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: morphine sulfate sustained-release capsules, Drug: KADIAN (morphine sulfate sustained-release) capsulesTreatment A (test product) followed by Treatment B (reference product) |
| 2 | Other | Drug: morphine sulfate sustained-release capsules, Drug: KADIAN (morphine sulfate sustained-release) capsulesTreatment B (reference product) followed by Treatment A (test product) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must be a male or non-pregnant, non-breast-feeding female.
- Subject must be between 18 and 50 years of age inclusive.
- Subject's body weight should be within +/- 15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table and 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, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
Key exclusion criteria (14 listed)
- 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 or clinical laboratory results at screening.
- History or presence of allergic or adverse response to the study drug 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.
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 |
|---|---|---|
| morphine sulfate sustained-release capsulesAlso: Treatment A, Test product1 x 200 mg, single-dose capsule | Drug | 1, 2 |
| KADIAN (morphine sulfate sustained-release) capsulesAlso: Treatment B, Reference product2 x 100 mg, single-dose capsule | Drug | 1, 2 |
Primary outcome
Maximum Plasma Morphine Concentration
Time frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
calculated from drug concentration over time
3 secondary outcomes
Time of Maximum Plasma Morphine Concentration
Time frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
Time frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose
Area Under the Curve to Infinity for Plasma Morphine
Time frame: 0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel V. Freeland, DO principal investigator
CEDRA Clinical Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing morphine sulfate sustained-release capsules and KADIAN (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 6 inclusion and 14 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 17 Aug 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Plasma Morphine Concentration (time frame: 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs 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 17 Aug 2010.