THCPhase 1NCT03098940
A Bioavailability Study on Dronabinol
A Phase 1 study testing Chewing Gum in people with THC, run by Axim Biotechnologies.
Trial summary
This study is a two part study Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- THC
- What is being tested?
- Chewing Gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Sep 2018
- 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, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.
Who cannot join
- Smokers
About this study
Official title: A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers
This study is a two part study
Read the detailed description
This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions
- Conditions
- THC
- Being tested
- Chewing Gum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing GumDrug
During the study healthy subjects will receive single doses of the various strengths of dronabinol
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Experimental | Chewing gum with various doses of dronabinol Receives: Drug: Chewing Gum |
| Capsule (Marinol) | Active comparator | Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol Receives: Drug: Chewing Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
based on Peak Plasma Concentration (Cmax)
Measured: up to 48 hours post-dose
Bioequivalence
based on Area under the plasma concentration versus time curve (AUC)
Measured: up to 48 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 posted4 Apr 2017
- Study startJan 2018 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THCStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axim Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098940
- Sponsor's protocol ID
- MedChew
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT03098940
- Acronym / sponsor ID
- MedChew
- Conditions
- THC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Axim BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2018 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 4 Apr 2017 (actual)
- 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 study is a two part study
Detailed description
This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Experimental | Drug: Chewing GumChewing gum with various doses of dronabinol |
| Capsule (Marinol) | Active comparator | Drug: Chewing GumMarinol is a product manufactured by AbbVie Capsule with various strengths of Marinol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.
Key exclusion criteria (1 listed)
- Smokers
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 |
|---|---|---|
| Chewing GumDuring the study healthy subjects will receive single doses of the various strengths of dronabinol | Drug | Capsule (Marinol), Chewing gum |
Primary outcome
Bioequivalence
Time frame: up to 48 hours post-dose
based on Peak Plasma Concentration (Cmax)
Bioequivalence
Time frame: up to 48 hours post-dose
based on Area under the plasma concentration versus time curve (AUC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No
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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 Chewing Gum in people with THC, run by Axim Biotechnologies.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. 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?
Results are not available in the source record.
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 (time frame: up to 48 hours post-dose). The study lists 2 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 4 Apr 2017.