HealthyPhase 1NCT01665222
Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fasting Conditions
A Phase 1 study testing Morphine Sulfate in people with Healthy, run by Ranbaxy Inc..
Trial summary
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other. Read more about this study
- Who is it for?
- Ages 20 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Morphine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Dec 2006
- Phase
- Phase 1
- 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 20 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For inclusion into the trial, subjects were required to fulfill all of the following criteria:
- Healthy subjects at least 18 years of age.
- Willingness to provide written informed consent after being informed of the nature of the study.
- Body mass index (BMI) between 18 and 30 and a weight of at least 110 pounds.
- Good health as determined by a lack of clinically significant abnormalities in health assessments performed at Screening, as judged by the physician.
Who cannot join
- Any of the following was regarding as a criterion for excluding subjects from the trial:
- Hypersensitivity to morphine sulfate (MS Contin®), naltrexone (ReVia®), or related compounds.
- Conditions that affected the absorption, metabolism, or passage of drugs out of the body (eg, sprue, celiac disease, Crohn's disease, colitis, liver, kidney, or thyroid conditions).
- Recent history (within 1 year) of mental illness, drug addiction, drug abuse, or alcoholism.
- A hematocrit value of ≤ 33.0% for females and ≤ 37.0% for males.
- Donation of > 500 mL of blood in the past 8 weeks prior to study drug dosing or difficulty in donating blood.
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- Receipt of an investigational drug within the 4 weeks prior to study drug dosing.
- Current use of any systemic prescription medications, except for oral/cutaneous/vaginal/injectable hormone contraceptives, within the 7 days prior to study drug dosing or over-the-counter (OTC) medication within 3 days of study drug dosing. This prohibition did not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications, as judged by the attending physician. Any nonprescription medication consumption reported was to be reviewed by the investigator prior to dosing. At the discretion of the investigator, these volunteers could be enrolled if the medication was not anticipated to alter study integrity or the safety of the subject.
- Regular smoking of more than 5 cigarettes weekly or the regular daily use of nicotine containing products beginning 3 months before study drug administration through the final evaluation. Subjects had to be able to refrain from smoking while confined in the clinic.
- Female subjects who were lactating or had a positive pregnancy test at Screening and prior to each of the treatment periods. Females were to use a medically acceptable method of contraception throughout the entire study period and for 1 week after study completion. Medically acceptable methods of contraception that could have been used by the subject and/or her partner were oral contraceptives/patches, progestin injection or implants, condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), vaginal spermicidal or hormonal suppository, surgical sterilization of themselves or their partner(s), or abstinence. Females using contraceptive medications/devices must have used them consistently for at least 3 months prior to receiving study drug.
- Alcohol, grapefruit beverages or foods, caffeine, or xanthine beverages or foods beginning 48 hours before each study drug administration through the last pharmacokinetic (PK) sample of each treatment period.
- Such restricted items included coffee, tea, iced tea, Coke®, Pepsi®, Mountain Dew®, chocolate, brownies, etc.
- Regular use of any drugs known to induce or inhibit hepatic drug metabolism (examples include barbiturates, carbamazepine, rifampin, phenylhydantoins, phenothiazines, cimetidine, omeprazole, macrolides, imidazoles, fluoroquinolones) within 30 days prior to study drug administration.
- Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C antibody at Screening.
- Positive test results for drugs of abuse or pregnancy at Screening and prior to each study drug dosing period.
- Subjects having emesis after either dose of naltrexone administered prior to the study drug were not to be continued in the study.
About this study
Official title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets in Healthy Volunteers.
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
Read the detailed description
This was a single center, single-dose, randomized, open-label, two-treatment, two-period crossover bioequivalence study designed to evaluate the pharmacokinetics and bioequivalence of morphine sulfate formulations under fasted conditions. Normal healthy males and females at least 18 years of age were screened for enrollment into the trial.
Potential subjects who met the eligibility criteria randomly received either oral Morphine Sulfate 60 mg Extended-release tablets or oral MS Contin® 60 mg Controlled-release tablets on Day 1 in Period 1, then, following the washout period, they were dosed on Day 8 in Period 2 with the other treatment. There was a 7-day washout period between dosing. The study drug treatments were administered after almost a 12-hour fast. Fasting continued until slightly over 4 hours post-dose for both treatment groups. All enrolled subjects were administered single oral doses of 50 mg of naltrexone hydrochloride 10 hours predose, 1 hour predose, and 12 hours post-dose of the study drug treatment on Day -1 and Day 1 in Period 1 and on Day 7 and Day 8 in Period 2.
Potential subjects (ie, alternates) were administered single oral doses of 50 mg of naltrexone hydrochloride 10 hours predose and 1 hour predose of the study drug treatment on Day -1 and Day 1 in Period 1. Subjects visited the clinic at AAIPharma at Screening (within 28 days prior to dosing) to assess eligibility and returned to the clinic on Day -1 for the Period 1 confinement period that lasted through Day 2. To complete Period 1, subjects were to return on Day 3 for the collection of pharmacokinetic blood samples. Period 1 dosing was followed by the 7-day washout period. Subjects returned to the clinic for the Period 2 confinement period on Day 7, which continued through Day 9. To complete Period 2, subjects were to return on Day 10 in that period for the collection of pharmacokinetic and safety blood samples.
Pharmacokinetic and safety assessments were performed during the conduct of the trial. Blood samples for the evaluation of morphine and morphine-6-glucuronide plasma concentrations were obtained while subjects were at the clinic and after discharge, as appropriate. Pharmacokinetic samples were collected over a 48-hour period of time following administration of the study drug treatment.
Medical care of the subjects was assured by the presence of a physician for at least 4 hours post-dose, and the physician remained on-call to treat adverse events (AEs). Professional medical personnel were on-site during the entire study confinement period. Adverse event information elicited during Confinement at the clinic or during telephone contacts was reviewed and documented.
- Conditions
- Healthy
- Being tested
- Morphine Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Morphine Sulfate 60mg Extended-release tablets
| Study group | Role | What they receive |
|---|---|---|
| Morphine Sulfate 60mg Extended-release tablets | Experimental | A single oral dose of Morphine Sulfate 60mg Extended-release tablets of Ohm Laboratories Inc. Receives: Drug: Morphine Sulfate |
| MS Contin® 60 mg Controlled-release tablets | Active comparator | A single oral dose of MS Contin® 60 mg Controlled-release tablets of Purdue Pharma L.P. Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics
Cmax, Area Under Curve and Tmax
Measured: predose and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.333, 3.667, 4, 5, 6, 8, 10, and 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startOct 2006
- Primary completionOct 2006
- Study completionDec 2006
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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665222
- Sponsor's protocol ID
- AAI-US-456
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Two-Way Crossover Fasted Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01665222
- Acronym / sponsor ID
- AAI-US-456
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ranbaxy Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Aug 2012 (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 study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
Detailed description
This was a single center, single-dose, randomized, open-label, two-treatment, two-period crossover bioequivalence study designed to evaluate the pharmacokinetics and bioequivalence of morphine sulfate formulations under fasted conditions. Normal healthy males and females at least 18 years of age were screened for enrollment into the trial.
Potential subjects who met the eligibility criteria randomly received either oral Morphine Sulfate 60 mg Extended-release tablets or oral MS Contin® 60 mg Controlled-release tablets on Day 1 in Period 1, then, following the washout period, they were dosed on Day 8 in Period 2 with the other treatment. There was a 7-day washout period between dosing. The study drug treatments were administered after almost a 12-hour fast. Fasting continued until slightly over 4 hours post-dose for both treatment groups. All enrolled subjects were administered single oral doses of 50 mg of naltrexone hydrochloride 10 hours predose, 1 hour predose, and 12 hours post-dose of the study drug treatment on Day -1 and Day 1 in Period 1 and on Day 7 and Day 8 in Period 2.
Potential subjects (ie, alternates) were administered single oral doses of 50 mg of naltrexone hydrochloride 10 hours predose and 1 hour predose of the study drug treatment on Day -1 and Day 1 in Period 1. Subjects visited the clinic at AAIPharma at Screening (within 28 days prior to dosing) to assess eligibility and returned to the clinic on Day -1 for the Period 1 confinement period that lasted through Day 2. To complete Period 1, subjects were to return on Day 3 for the collection of pharmacokinetic blood samples. Period 1 dosing was followed by the 7-day washout period. Subjects returned to the clinic for the Period 2 confinement period on Day 7, which continued through Day 9. To complete Period 2, subjects were to return on Day 10 in that period for the collection of pharmacokinetic and safety blood samples.
Pharmacokinetic and safety assessments were performed during the conduct of the trial. Blood samples for the evaluation of morphine and morphine-6-glucuronide plasma concentrations were obtained while subjects were at the clinic and after discharge, as appropriate. Pharmacokinetic samples were collected over a 48-hour period of time following administration of the study drug treatment.
Medical care of the subjects was assured by the presence of a physician for at least 4 hours post-dose, and the physician remained on-call to treat adverse events (AEs). Professional medical personnel were on-site during the entire study confinement period. Adverse event information elicited during Confinement at the clinic or during telephone contacts was reviewed and documented.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine Sulfate 60mg Extended-release tablets | Experimental | Drug: Morphine SulfateA single oral dose of Morphine Sulfate 60mg Extended-release tablets of Ohm Laboratories Inc. |
| MS Contin® 60 mg Controlled-release tablets | Active comparator | Drug: Morphine SulfateA single oral dose of MS Contin® 60 mg Controlled-release tablets of Purdue Pharma L.P. |
Who may qualify
- Ages
- 20 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- For inclusion into the trial, subjects were required to fulfill all of the following criteria:
- Healthy subjects at least 18 years of age.
- Willingness to provide written informed consent after being informed of the nature of the study.
- Body mass index (BMI) between 18 and 30 and a weight of at least 110 pounds.
- Good health as determined by a lack of clinically significant abnormalities in health assessments performed at Screening, as judged by the physician.
Key exclusion criteria (16 listed)
- Hypersensitivity to morphine sulfate (MS Contin®), naltrexone (ReVia®), or related compounds.
- Conditions that affected the absorption, metabolism, or passage of drugs out of the body (eg, sprue, celiac disease, Crohn's disease, colitis, liver, kidney, or thyroid conditions).
- Recent history (within 1 year) of mental illness, drug addiction, drug abuse, or alcoholism.
- A hematocrit value of ≤ 33.0% for females and ≤ 37.0% for males.
- Donation of > 500 mL of blood in the past 8 weeks prior to study drug dosing or difficulty in donating blood.
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 SulfateMorphine Sulfate 60mg Extended-release tablets | Drug | MS Contin® 60 mg Controlled-release tablets, Morphine Sulfate 60mg Extended-release tablets |
Primary outcome
Composite of Pharmacokinetics
Time frame: predose and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.333, 3.667, 4, 5, 6, 8, 10, and 12 hours post-dose
Cmax, Area Under Curve and Tmax
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 15 Aug 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Morphine Sulfate in people with Healthy, run by Ranbaxy Inc..
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 5 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Composite of Pharmacokinetics (time frame: predose and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.333, 3.667, 4, 5, 6, 8, 10, and 12 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 15 Aug 2012.