PharmacokineticsPhase 1NCT06574100
Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
A Phase 1 study testing Cannabidiol in people with Pharmacokinetics, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 26 Oct 2024to Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 35 years old
- Clinical labs within the stated normal range of the Royal University Hospital Test Centre, or values outside the stated normal range that are not of clinical significance as determined by the qualified investigator.
- No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.
- Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.
- Ability to return for blood draws in the subsequent days.
Who cannot join
- History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects.
- History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
- Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)
- Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
- Personal or family history of schizophrenia or any other psychotic disorder
- Current or past drug or alcohol dependence or abuse
Show all 16Show fewer
- Use of Cannabis-based therapy within 2 months (Participants who have previously used a Cannabis-based therapy may be included if they have a 2-month period without use of Cannabis-based therapy prior to enrolment in the study)
- Use of recreational Cannabis within 2 months (Participants who have previously used recreational Cannabis may be included if they have a 2-month period without use of recreational Cannabis prior to enrolment in the study)
- Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week
- Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week
- Use of any other medication known to interact with medicinal Cannabis within one week.
- Allergy or known intolerance to any of the compounds within the study preparation.
- Resting heart rate HR < 50 bpm or > 100 bpm or seated blood pressure < 100/60 or higher than 140/90
- Inability of study participants to attend and complete all study visits
- Bleeding disorder
- Known low hematocrit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 5E5
Abdul Salama, PharmD, 3065600094, abs915@usask.ca
Jane Alcorn, DVM;PhD, (306) 966-6365, jane.alcorn@usask.ca
About this study
This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.
Read the detailed description
Cannabis formulations are typically administered by the oral route of administration. This route represents the most common administration route for most pharmaceuticals due to the ease of administration and convenience. Inhalational products are not acceptable for the sport's athlete population due to potential damage to lung tissues. Topical products do not have adequate bioavailability to meet our therapeutic objectives. Our PK studies, then, need to employ the same dosage form and route of administration we expect to use in future clinical efficacy trials.
Given the low bioavailability expected with CBD oral formulations, we wish to assess two different formulations and the relative extent of CBD absorption. Our future planned CBD intervention studies in athletes will require use of larger doses of CBD. The formulation with the larger bioavailability will help to reduce the overall size of the dose utilized and therefore reduce the amount of product exposure in our clinical intervention studies. This will increase the likelihood that a Cannabis company can supply the necessary amount of product and reduce the overall cost associated with the studies. Generally speaking, based on current literature published around CBD administration for therapeutic application, higher doses of CBD (i.e., 50mg/kg/d) were found to correlate to more positive outcomes than lower doses (i.e., 1mg/kg/d). Assuming an average weight of 70 kg, a 1000 mg dose would be around 14.29 mg/kg, and a 3000 mg dose around 42.86 mg/kg. This will allow us to investigate the pharmacokinetics of CBD on both ends of the hypothetical efficacy trend. Studies have examined single orally administered doses up to 6000 mg with no serious adverse effects reported.
- Conditions
- Pharmacokinetics
- Being tested
- Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called One formulation will be a powder the other will be buccal strips
Patients in the first arm cross-over will receive either a single bolus dose of 250mg buccally administered or 1000mg CBD powder and cross over to vice-versa after 21 days.
CannabidiolDrug
Patients will be randomised to receive 3000mg oral CBD fasting or Fed, they will the cross over to the other group 21 days following the first administration.
| Study group | Role | What they receive |
|---|---|---|
| Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulations | Active comparator | participants receiving the buccal formulation will be required to receive 10 strips by the cheeks, they will be instructed to only swallow at maximum once every 2 mins for the first 5 mins. This is to minimize the amount of CBD that will be carried into the GIT. This buccal administration group will receive 2 strips at a time, one on each cheek side, following 5 mins of dissolving, patients will receive 100mL of water to swish the residue in their mouths and swallow, then receive another pair of strips to repeat the process for a total of 5 times over the course of 30 minutes (i.e., 10 strips total). The group receiving the 1000mg oral CBD extract will mimic the buccal group in that they will receive that dose over the course of 30 minutes in 5 parts, 200mg per part, and will drink 100mL of water to accompany its administration Receives: Drug: Cannabidiol |
| Single Oral Dose Administration of 3000mg CBD Extract in Fed vs Fasting | Active comparator | In the fasting group, participants will be asked to fast overnight (at least 10 hours fast) but are allowed to drink water.In the fed state group, participants will start their meal 30 minutes prior to receiving the dose. The meal will consist of high caloric (800-1000 Cal), high fat (~50% of total calories), with protein, and carbohydrates (~150 kcal, and ~250 kcal, respectively) content. No food will be administered 4 hours after the dose, and no water will be given 1 hour prior to dose administration and 1 hour after administration. The dose will be given however with a total of 235 mL of water. Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters
relative bioavailability (F)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
time to maximum plasma concentration (Tmax)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
maximum plasma concentration (Cmax)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
log-linear terminal phase rate constant (k)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
area under the plasma concentration versus time curve (AUC)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
absorption rate constant (ka)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
apparent clearance (Cl/F)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
apparent volume of distribution (Vd/F)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Pharmacokinetic Parameters
half-life
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Secondary outcomes (14)
Safety of the drug using the Integrated Addendum to ICH E6(R1)
Safety of the study drug will be determined by measuring blood pressure (mmhg)
Measured: During the first week of administration and the 4th week of administration
Safety of the drug using the Integrated Addendum to ICH E6(R1)
Safety of the study drug will be determined by measuring heart rate (beats/minute)
Measured: During the first week of administration and the 4th week of administration
Safety of the drug using the Integrated Addendum to ICH E6(R1)
Safety will be assessed by reporting of incidence of adverse events for each participant.
Measured: During the first week of administration and the 4th week of administration
Optimal washout periods
Measure CBD and it's metabolites over the course of the study to determine what the optimal washout period is for future studies
Measured: 3 weeks
Tolerability of the drug using the Integrated Addendum to ICH E6(R1)
Tolerability of the study drug will be determined by reporting of incidence of adverse events for each participant.
Measured: During the first week of administration and the 4th week of administration
Compare Fed vs Fast state on oral absorption kinetics
half-life
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
apparent volume of distribution (Vd/F)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
apparent clearance (Cl/F)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
absorption rate constant (ka)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
area under the plasma concentration versus time curve (AUC)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
log-linear terminal phase rate constant (k)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
maximum plasma concentration (Cmax)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
time to maximum plasma concentration (Tmax)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
relative bioavailability (F)
Measured: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start26 Oct 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We plan this study as a single-site (potentially multi-site), randomized, two-arm study, with one arm being a two-sequence crossover, single buccal, or oral dose in fasted healthy male adults, and the second arm being a two-sequence cross-over, single high oral dose PK study in fasted vs fed-state healthy male adults. Participants will be randomized into four groups (n = 16 in Arm 1, 8 per group (2 groups), all males; n = 4 in Arm 2, 2 per group (2 groups) all males) (ages 18 - 35) based on which formulation each group will receive. Individuals in study arm 1 will complete the study in the fasted state (10 hours of fasting). Individuals in study arm 2 will follow the fed-state protocol as outlined by the United States FDA's bioequivalent studies guideline
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regina
- Responsible party
- Principal investigator, Jane Alcorn, University of Saskatchewan
- Investigators
- Payam Dehghani, MD, Principal investigator, Pasqua HospitalJane Alcorn, DVM;PhD, Principal investigator, University of SaskatchewanAbdul Salama, PharmD, Study director, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574100
- Sponsor's protocol ID
- NFL-CBD-02
- Other IDs
- Bio-4317, 286992
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT06574100
- Acronym / sponsor ID
- NFL-CBD-02
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Regina
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 27 Aug 2024 (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 project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.
Detailed description
Cannabis formulations are typically administered by the oral route of administration. This route represents the most common administration route for most pharmaceuticals due to the ease of administration and convenience. Inhalational products are not acceptable for the sport's athlete population due to potential damage to lung tissues. Topical products do not have adequate bioavailability to meet our therapeutic objectives. Our PK studies, then, need to employ the same dosage form and route of administration we expect to use in future clinical efficacy trials.
Given the low bioavailability expected with CBD oral formulations, we wish to assess two different formulations and the relative extent of CBD absorption. Our future planned CBD intervention studies in athletes will require use of larger doses of CBD. The formulation with the larger bioavailability will help to reduce the overall size of the dose utilized and therefore reduce the amount of product exposure in our clinical intervention studies. This will increase the likelihood that a Cannabis company can supply the necessary amount of product and reduce the overall cost associated with the studies. Generally speaking, based on current literature published around CBD administration for therapeutic application, higher doses of CBD (i.e., 50mg/kg/d) were found to correlate to more positive outcomes than lower doses (i.e., 1mg/kg/d). Assuming an average weight of 70 kg, a 1000 mg dose would be around 14.29 mg/kg, and a 3000 mg dose around 42.86 mg/kg. This will allow us to investigate the pharmacokinetics of CBD on both ends of the hypothetical efficacy trend. Studies have examined single orally administered doses up to 6000 mg with no serious adverse effects reported.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We plan this study as a single-site (potentially multi-site), randomized, two-arm study, with one arm being a two-sequence crossover, single buccal, or oral dose in fasted healthy male adults, and the second arm being a two-sequence cross-over, single high oral dose PK study in fasted vs fed-state healthy male adults. Participants will be randomized into four groups (n = 16 in Arm 1, 8 per group (2 groups), all males; n = 4 in Arm 2, 2 per group (2 groups) all males) (ages 18 - 35) based on which formulation each group will receive. Individuals in study arm 1 will complete the study in the fasted state (10 hours of fasting). Individuals in study arm 2 will follow the fed-state protocol as outlined by the United States FDA's bioequivalent studies guideline
| Arm | Type | Receives |
|---|---|---|
| Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulations | Active comparator | Drug: Cannabidiolparticipants receiving the buccal formulation will be required to receive 10 strips by the cheeks, they will be instructed to only swallow at maximum once every 2 mins for the first 5 mins. This is to minimize the amount of CBD that will be carried into the GIT. This buccal administration group will receive 2 strips at a time, one on each cheek side, following 5 mins of dissolving, patients will receive 100mL of water to swish the residue in their mouths and swallow, then receive another pair of strips to repeat the process for a total of 5 times over the course of 30 minutes (i.e., 10 strips total). The group receiving the 1000mg oral CBD extract will mimic the buccal group in that they will receive that dose over the course of 30 minutes in 5 parts, 200mg per part, and will drink 100mL of water to accompany its administration |
| Single Oral Dose Administration of 3000mg CBD Extract in Fed vs Fasting | Active comparator | Drug: CannabidiolIn the fasting group, participants will be asked to fast overnight (at least 10 hours fast) but are allowed to drink water.In the fed state group, participants will start their meal 30 minutes prior to receiving the dose. The meal will consist of high caloric (800-1000 Cal), high fat (~50% of total calories), with protein, and carbohydrates (~150 kcal, and ~250 kcal, respectively) content. No food will be administered 4 hours after the dose, and no water will be given 1 hour prior to dose administration and 1 hour after administration. The dose will be given however with a total of 235 mL of water. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 - 35 years old
- Clinical labs within the stated normal range of the Royal University Hospital Test Centre, or values outside the stated normal range that are not of clinical significance as determined by the qualified investigator.
- No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.
- Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.
- Ability to return for blood draws in the subsequent days.
Key exclusion criteria (16 listed)
- History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects.
- History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
- Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)
- Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
- Personal or family history of schizophrenia or any other psychotic disorder
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 |
|---|---|---|
| CannabidiolAlso: One formulation will be a powder the other will be buccal stripsPatients in the first arm cross-over will receive either a single bolus dose of 250mg buccally administered or 1000mg CBD powder and cross over to vice-versa after 21 days. | Drug | Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulations |
| CannabidiolPatients will be randomised to receive 3000mg oral CBD fasting or Fed, they will the cross over to the other group 21 days following the first administration. | Drug | Single Oral Dose Administration of 3000mg CBD Extract in Fed vs Fasting |
Primary outcome
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
relative bioavailability (F)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
time to maximum plasma concentration (Tmax)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
maximum plasma concentration (Cmax)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
log-linear terminal phase rate constant (k)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
area under the plasma concentration versus time curve (AUC)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
absorption rate constant (ka)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
apparent clearance (Cl/F)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
apparent volume of distribution (Vd/F)
Pharmacokinetic Parameters
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
half-life
14 secondary outcomes
Safety of the drug using the Integrated Addendum to ICH E6(R1)
Time frame: During the first week of administration and the 4th week of administration
Safety of the drug using the Integrated Addendum to ICH E6(R1)
Time frame: During the first week of administration and the 4th week of administration
Safety of the drug using the Integrated Addendum to ICH E6(R1)
Time frame: During the first week of administration and the 4th week of administration
Optimal washout periods
Time frame: 3 weeks
Tolerability of the drug using the Integrated Addendum to ICH E6(R1)
Time frame: During the first week of administration and the 4th week of administration
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Compare Fed vs Fast state on oral absorption kinetics
Time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Payam Dehghani, MD principal investigator
Pasqua Hospital
Jane Alcorn, DVM;PhD principal investigator
University of Saskatchewan
Abdul Salama, PharmD study director
University of Saskatchewan
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 Cannabidiol in people with Pharmacokinetics, run by University of Saskatchewan at 1 site in Canada.
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: looking for participants now, as of the sponsor's last update on 30 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdul Salama, PharmD (3065600094, abs915@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameters (time frame: 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over). 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 30 Mar 2025.