To Determine Bioequivalence Under Fasting ConditionsPhase 1NCT01380457
Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
A Phase 1 study testing Dronabinol and Marinol in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fasting Conditions
- What is being tested?
- Dronabinol and Marinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers, 18 - 55 years of age
- Subjects must be within 18 to 29.9 kilograms/m2 per the BMI
- General good health as determined by medical history and physical examination within 30 days prior to the start of the study
- Blood chemistry, hematology, and urinalysis tests will be performed within 30 days prior to the start of the study
- No participation in an investigational drug study or donation of blood within 30 days prior to the start of the study
- At screening, subjects must have blood pressure and pulse rate within specified ranges
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- No grapefruit juice or grapefruit-containing products for at least 72 hours prior to drug administration, each period. Subjects will be queried at check-in each period on consumption of grapefruit juice or grapefruit containing products. Results will be recorded and reported in the final report.
- No alcohol consumption for at least 24 hours prior to drug administration, each period
- No caffeine or xanthine consumption for 48 hours prior prior to drug administration, each period
- No prescription drugs (excluding hormonal contraceptives) within 14 days prior to drug administration, each period
- Subjects should refrain from taking OTC preparations, and/or nutritional supplements within 7 days prior to drug administration, each period. Subjects shall refrain from taking herbal remedies within 14 day prior to drug administration, and throughout the study periods
- Female subjects must not be pregnant or nursing; and must be surgically sterile; one year post-menopausal; or on hormonal contraceptive agents), a diaphragm or condom with spermicidal foam or jelly, or IUD for at least 3 months prior to drug administration and agree to use the same method of contraception for at least 1 month after the last drug administration
- Negative serum pregnancy test at screening and negative urine pregnancy test prior to drug administration, each period
- Negative HIV 1, hepatitis B surface antigen, an urine screen for drugs of abuse within 30 days prior to the start of the study
Who cannot join
- Disease or condition that could impact interpretation of study results or a condition which treatment would be contraindicated per currently approved product labeling
- Subjects had any of the following conditions:
- used any prescription or OTC medication within 14 days of study initiation
- a positive urine test for illicit drugs
- participated in a clinical investigation within the past 30 days
- had clinically significant allergies to drugs or foods, ot
- any condition that might place them at increased risk of complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.
Read the detailed description
To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.
- Being tested
- Dronabinol, Marinol
- Keywords
- bioequivalence, 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.
DronabinolDrug
Also called Marinol
Capsules, 10 mg, single dose, fasting conditions
MarinolDrug
Also called Dronabinol
Capsules, 10 mg, single-dose, fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions Receives: Drug: Dronabinol |
| B | Active comparator | Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc. Receives: Drug: Marinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2006
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fasting ConditionsStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BASi Clinical Research Unit
- Investigators
- Dilip K Guha-Ray, M.D., Principal investigator, BASi Baltimore Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380457
- Sponsor's protocol ID
- 11885
- Status last verified
- Jun 2011
- First submitted
- 16 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01380457
- Acronym / sponsor ID
- 11885
- Keywords
- bioequivalence, dronabinol, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BASi Clinical Research Unit
- Study start
- Jan 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Jun 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.
The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.
Detailed description
To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: DronabinolSubjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions |
| B | Active comparator | Drug: MarinolSubjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy volunteers, 18 - 55 years of age
- Subjects must be within 18 to 29.9 kilograms/m2 per the BMI
- General good health as determined by medical history and physical examination within 30 days prior to the start of the study
- Blood chemistry, hematology, and urinalysis tests will be performed within 30 days prior to the start of the study
- No participation in an investigational drug study or donation of blood within 30 days prior to the start of the study
Key exclusion criteria (7 listed)
- Disease or condition that could impact interpretation of study results or a condition which treatment would be contraindicated per currently approved product labeling
- Subjects had any of the following conditions:
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 |
|---|---|---|
| DronabinolAlso: MarinolCapsules, 10 mg, single dose, fasting conditions | Drug | A |
| MarinolAlso: DronabinolCapsules, 10 mg, single-dose, fasting conditions | Drug | B |
Primary outcome
Bioequivalence
To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.
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 27 Jun 2011.
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.
Dilip K Guha-Ray, M.D. principal investigator
BASi Baltimore Clinical Research Unit
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 and Marinol in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, 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 14 inclusion and 7 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 27 Jun 2011. 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?
Bioequivalence. 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 27 Jun 2011.