BioavailabilityPhase 1NCT01448772
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
A Phase 1 study testing Dronabinol Capsules, 5 mg and Dronabinol Oral Solution in people with Bioavailability, run by INSYS Therapeutics Inc at 1 site in United States.
Trial summary
This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Dronabinol Capsules, 5 mg and Dronabinol Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2011
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female healthy subjects between 18 and 55 years of age, inclusive.
- Subjects must have a body mass index (BMI) within 19 and 29.9 kg/m2, inclusive and weigh a minimum of 50 kg (110 pounds).
- Subjects must be in general good health as determined by medical history, physical examination, or laboratory evaluations conducted at the screening visit and upon admission to the clinic. Examination should include a thorough examination of oral cavity for any abnormal findings.
- Subjects must be non-smokers, defined as not having used any tobacco products in the past six months. Negative results from a urine cotinine test conducted at Screening.
- Subjects must be able to provide informed consent after risks and benefits have been explained, and be willing to comply with study procedures.
- Female subjects of childbearing potential must not be pregnant or nursing; and must be surgically sterile; one year postmenopausal; or on hormonal contraceptive agent(s), diaphragm or condom with spermicidal foam or jelly, or IUD for at least three months prior to drug administration and agree to use the same method of contraception for at least one month after the last drug administration.
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- Negative urine pregnancy test at screening and prior to drug administration of each period.
- Negative HIV 1, hepatitis C virus (HCV) antibody, hepatitis B surface antigen within 30 days prior to the start of the study.
- Negative results from screening for drugs of abuse at Screening and Day-1 (check-in) prior to drug administration during all study periods.
Who cannot join
- Known hypersensitivity or allergy to dronabinol, Marinol, marijuana, hashish, or sesame oil.
- Have participated in an investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the time of first study dose in this study.
- Presence of visible signs of an infection, mucositis, cold sores, lesions, local irritation, periodontal disease of the oral cavity or any abnormal finding in the oral cavity. In addition, evidence of piercings of the tongue, lip, or anywhere in the oral cavity or a history of oral cavity piercings.
- Have donated or received blood or blood products within 30 days prior to the first study dose.
- Have received any prescription drug (excluding hormonal contraceptives) within 14 days of study drug administration, over-the-counter drugs within seven days of study drug administration, and/or vitamins or herbal supplements within three days of study drug administration.
- Significant bradycardia or tachycardia defined as having a resting heart rate <45 bpm or >100 bpm, respectively.
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- Clinical evidence of either hypotension (defined as systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg), or hypertension (defined as systolic blood pressure >139 mmHg or diastolic blood pressure >89 mmHg).
- Any history of clinically significant organ system (cardiovascular, neurological, hepatic, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal) disorders or ongoing infectious diseases; or any other conditions that might interfere with the absorption, distribution, metabolism or excretion of the study drug, or that would place the subject at increased risk.
- Use of marijuana (directly or indirectly) within 90 days prior to drug administration and during the course of the study.
- History of treatment for alcohol abuse, significant mental illness, physical dependence to any opioid, barbiturates, amphetamines, cocaine, or benzodiazepines in the past 10 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Drug Development Solutions
Austin, Texas, 78754
About this study
Official title: A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions
This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.
- Conditions
- Bioavailability
- Being tested
- Dronabinol Capsules, 5 mg, Dronabinol Oral Solution
- Keywords
- Dronabinol, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol Capsules, 5 mgDrug
Comparison of different routes of administration of a drug using the approved Abbott 5 mg capsule product under fasting conditions; two treatment periods with a washout period separating the study periods
Dronabinol Oral SolutionDrug
Comparison of different routes of administration of a drug using a proposed oral solution formulation under fasting conditions; two treatment periods with a washout period separating the study periods
| Study group | Role | What they receive |
|---|---|---|
| Marinol | Active comparator | Not described Receives: Drug: Dronabinol Capsules, 5 mg |
| oral solution | Experimental | Not described Receives: Drug: Dronabinol Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption
The plasma concentration versus time data of dronabinol and its metabolite (11-hydroxy-delta-9-tetrahydrocannabinol) will be analyzed. The PK parameters Cmax, AUC0-t and AUCinf for delta-9-tetrahydrocannabinol will be calculated and used as the measures for comparative bioavailability assessment of dronabinol oral solution versus the innovator capsule product.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Juren, M.D., Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448772
- Sponsor's protocol ID
- INS-10-012
- Status last verified
- Mar 2012
- First submitted
- 5 Oct 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Replicate Crossover Design Comparative Bioavailability Study of Dronabinol Oral Solution 5 mg Versus Marinol Capsules 5 mg Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT01448772
- Acronym / sponsor ID
- INS-10-012
- Conditions
- Bioavailability
- Keywords
- Dronabinol, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Oct 2011 (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.
This is a comparative study to assess bioavailability of a proposed alternate dosage form against the current FDA-approved branded product.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marinol | Active comparator | Drug: Dronabinol Capsules, 5 mg |
| oral solution | Experimental | Drug: Dronabinol Oral Solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female healthy subjects between 18 and 55 years of age, inclusive.
- Subjects must have a body mass index (BMI) within 19 and 29.9 kg/m2, inclusive and weigh a minimum of 50 kg (110 pounds).
- Subjects must be in general good health as determined by medical history, physical examination, or laboratory evaluations conducted at the screening visit and upon admission to the clinic. Examination should include a thorough examination of oral cavity for any abnormal findings.
- Subjects must be non-smokers, defined as not having used any tobacco products in the past six months. Negative results from a urine cotinine test conducted at Screening.
- Subjects must be able to provide informed consent after risks and benefits have been explained, and be willing to comply with study procedures.
Key exclusion criteria (10 listed)
- Known hypersensitivity or allergy to dronabinol, Marinol, marijuana, hashish, or sesame oil.
- Have participated in an investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the time of first study dose in this study.
- Presence of visible signs of an infection, mucositis, cold sores, lesions, local irritation, periodontal disease of the oral cavity or any abnormal finding in the oral cavity. In addition, evidence of piercings of the tongue, lip, or anywhere in the oral cavity or a history of oral cavity piercings.
- Have donated or received blood or blood products within 30 days prior to the first study dose.
- Have received any prescription drug (excluding hormonal contraceptives) within 14 days of study drug administration, over-the-counter drugs within seven days of study drug administration, and/or vitamins or herbal supplements within three days of study drug administration.
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 |
|---|---|---|
| Dronabinol Capsules, 5 mgComparison of different routes of administration of a drug using the approved Abbott 5 mg capsule product under fasting conditions; two treatment periods with a washout period separating the study periods | Drug | Marinol |
| Dronabinol Oral SolutionComparison of different routes of administration of a drug using a proposed oral solution formulation under fasting conditions; two treatment periods with a washout period separating the study periods | Drug | oral solution |
Primary outcome
Rate and extent of absorption
Time frame: 48 hours
The plasma concentration versus time data of dronabinol and its metabolite (11-hydroxy-delta-9-tetrahydrocannabinol) will be analyzed. The PK parameters Cmax, AUC0-t and AUCinf for delta-9-tetrahydrocannabinol will be calculated and used as the measures for comparative bioavailability assessment of dronabinol oral solution versus the innovator capsule product.
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 26 Mar 2012.
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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.
Joe Juren, M.D. principal investigator
Worldwide Clinical Trials
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 Dronabinol Capsules, 5 mg and Dronabinol Oral Solution in people with Bioavailability, run by INSYS Therapeutics 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 9 inclusion and 10 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 26 Mar 2012. 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?
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?
Rate and extent of absorption (time frame: 48 hours). 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 26 Mar 2012.