HealthyNCT02604992
Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers
A study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by INSYS Therapeutics Inc at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions. 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?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2015
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets protocol-specified criteria for qualification
- Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator
Who cannot join
- History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions
The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
- Conditions
- Healthy
- Being tested
- Treatment A, Treatment B, Treatment C
- Keywords
- Comparative Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Dronabinol oral solution, under fed conditions
Treatment BDrug
Also called Marinol
Dronabinol oral capsule, under fed conditions
Treatment CDrug
Also called Marinol
Dronabinol oral capsule, under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (A,B,C) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Group 2 (B,C,A) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Group 3 (C,A,B) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Group 4 (C,B,A) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Group 5 (A,C,B) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
| Group 6 (B,A,C) | Experimental | With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time 0 to the last measured concentration
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Area under the curve extrapolated to infinity
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Maximum plasma concentration
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Time to reach maximum plasma concentration
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Elimination rate constant
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
The time prior to the first measurable (non-zero) concentration
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Elimination half-life
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Apparent oral clearance
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Volume of distribution
Measured: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neha Parikh, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604992
- Sponsor's protocol ID
- INS004-15-059
- Status last verified
- Jan 2016
- First submitted
- 12 Nov 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT02604992
- Acronym / sponsor ID
- INS004-15-059
- Conditions
- Healthy
- Keywords
- Comparative Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Nov 2015 (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 is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (A,B,C) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CWith a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C. |
| Group 2 (B,C,A) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CWith a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A. |
| Group 3 (C,A,B) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CWith a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B. |
| Group 4 (C,B,A) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CWith a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A. |
| Group 5 (A,C,B) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CWith a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B. |
| Group 6 (B,A,C) | Experimental | Drug: Treatment A, Drug: Treatment B, Drug: Treatment CWith a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meets protocol-specified criteria for qualification
- Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator
Key exclusion criteria (5 listed)
- History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| Treatment ADronabinol oral solution, under fed conditions | Drug | Group 1 (A,B,C), Group 2 (B,C,A), Group 3 (C,A,B), Group 4 (C,B,A), Group 5 (A,C,B), Group 6 (B,A,C) |
| Treatment BAlso: MarinolDronabinol oral capsule, under fed conditions | Drug | Group 1 (A,B,C), Group 2 (B,C,A), Group 3 (C,A,B), Group 4 (C,B,A), Group 5 (A,C,B), Group 6 (B,A,C) |
| Treatment CAlso: MarinolDronabinol oral capsule, under fasted conditions | Drug | Group 1 (A,B,C), Group 2 (B,C,A), Group 3 (C,A,B), Group 4 (C,B,A), Group 5 (A,C,B), Group 6 (B,A,C) |
Primary outcome
Area under the curve from time 0 to the last measured concentration
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Area under the curve extrapolated to infinity
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Maximum plasma concentration
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Time to reach maximum plasma concentration
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Elimination rate constant
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
The time prior to the first measurable (non-zero) concentration
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Elimination half-life
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Apparent oral clearance
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Volume of distribution
Time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
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 20 Jan 2016.
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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.
Neha Parikh study director
INSYS Therapeutics Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment A, Treatment B and Treatment C in people with Healthy, 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 2 inclusion and 5 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 20 Jan 2016. 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.
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?
Area under the curve from time 0 to the last measured concentration (time frame: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.). The study lists 9 primary outcomes in all. 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 20 Jan 2016.