MigrainePhase 1NCT02954276
Comparative Bioavailability Study of Omexa Sumatriptan vs. Imitrex® in Healthy Volunteers
A Phase 1 study testing Omexa Sublingual Sumatriptan tablet and Imitrex Oral Product in people with Migraine, run by Targia Pharmaceuticals Ltd..
Trial summary
the trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Omexa Sublingual Sumatriptan tablet and Imitrex Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- 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
- Able to provide written informed consent
- Man and women volunteers 18-55 years of age
- Healthy with no clinically relevant abnormalities in the opinion of the investigator as determined by medical history, physical examination, urine analysis and vital signs.
- Have a BMI of 18-32 kg/m2, inclusive, and a body weight of not less than 50 kg
- Women of child-bearing potential who agree to use double contraceptive 14 days prior to the study, during whole duration of the study and 30 days after completion of the study.
- The volunteer agrees to abstain from alcohol intake 48 hours before each administration of study agent and during inpatient portion of the study
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- The volunteer agrees not to consume food or beverages containing, grapefruit or grapefruit juice 72 hours prior to study treatment and until after the last pharmacokinetic (PK) sample is collected
- The volunteer agrees to frequent blood withdrawal
- The volunteer doesn't have history of fear of needles and injections, or hemophobia (fear of blood)
Who cannot join
- Pregnant or breast-feeding women (women of child bearing potential must use double contraceptive and have the results of a negative pregnancy test recorded prior to study drug administration)
- Have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Volunteers with two or more risk factors for ischemic heart disease
- History of seizures
- History of moderate to severe hypertension or mild uncontrolled hypertension or systolic blood pressure above 140 or diastolic above 90 during screening visit
- Currently or history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator.
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- History of hypersensitivity or allergies to any drug compound, including Sumatriptan, any of its components or sulphonamides (Appendix 1).
- History of traumatic surgery within 12 weeks prior to screening, pre-planned surgery or procedures that would interfere with the conduct of the study.
- Have an acute illness within 7 days prior to study treatment or have had a major illness or hospitalization within 1 month prior to study treatment.
- History (within 1 year) of alcohol or drug abuse.
- Volunteers who are heavy smokers (more than 10 cigarettes a day) or use of nicotine-replacement therapy
- History of abnormal values for hematology, clinical chemistry, or urine analysis during six months prior to treatment considered clinically significant by the Investigator.
- Positive test for HIV antibodies at screening
- Positive HBsAg test at screening, or volunteers that did not bring a certificate for three doses of Hepatitis B vaccination.
- Known history of positive serology test for hepatitis C virus antibody (anti-HCV)
- Positive urine drug screen for substances of abuse including cocaine, cannabinoids, amphetamines, benzodiazepines, Subutex (BUP), opiates, and methadone at screening.
- Have donated blood or experienced significant blood loss (volume > 500 mL) within 3 months prior to screening, or is planning to donate within 2 months after completion of the study.
- Use of any monoamine oxidase inhibitors (MAOI) within 28 days prior to study treatment .
- Use of any prescription medications/products, except hormonal contraceptives, within 14 days prior to each of the study treatments.
- Use of any over the counter (OTC), nonprescription preparation (including minerals and phytotherapeutic/herbal/plant-derived preparations), within 14 days prior to each of the study treatments, with the exception of ibuprofen, and acetaminophen used at recommended doses.
- Participation in any other investigational study in which receipt of an investigational study treatment occurred within 4 weeks prior to dosing, or plan to participate in an investigational study less than 1 month after completion of the study.
- Any condition that in the opinion of the Investigator would complicate or compromise the study, or the well-being of the volunteer.
About this study
Official title: A Randomized, Open Label, Crossover, Bioavailability Study to Compare Omexa Sumatriptan Transmucosal Sublingual Tablet Versus Commercial Imitrex® Sumatriptan Oral Tablet in Healthy Volunteers
the trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.
Read the detailed description
Volunteers will randomly receive either the commercial oral tablet 100 mg Imitrex® or 75 mg Omexa sublingual tablet under fasted conditions. One week following the first administration, the volunteers will receive the alternative treatment.
Blood samples will be collected at each visit before drug administration and at 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min after drug administration, in order to characterize the drug's absorption and pharmacokinetics, as well as to evaluate Omexa formulation safety.
- Conditions
- Migraine
- Being tested
- Omexa Sublingual Sumatriptan tablet, Imitrex Oral Product
- Keywords
- safety
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omexa Sublingual Sumatriptan tabletDrug
75 mg
Imitrex Oral ProductDrug
Also called Sumatriptan
100 mg
| Study group | Role | What they receive |
|---|---|---|
| 75 mg Omexa sumatriptan sublingual tablet | Experimental | Not described Receives: Drug: Omexa Sublingual Sumatriptan tablet |
| 100 mg Imitrex oral tablet | Active comparator | Not described Receives: Drug: Imitrex Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach peak plasma concentration (Tmax)
Measured: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Peak Plasma concentration (Cmax)
Measured: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Area under the curve (AUC)
Measured: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Secondary outcomes (1)
Adverse events
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SoluBest Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954276
- Sponsor's protocol ID
- SB1705
- Other IDs
- 0189-15-WOMC
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Crossover, Bioavailability Study to Compare Omexa Sumatriptan Transmucosal Sublingual Tablet Versus Commercial Imitrex® Sumatriptan Oral Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02954276
- Acronym / sponsor ID
- SB1705
- Conditions
- Migraine
- Keywords
- safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Targia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- SoluBest Ltd.
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Nov 2016 (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 trial is a randomized, open label, crossover, single-administration bioavailability study to compare the pharmacokinetic parameters of Omexa sumatriptan transmucosal sublingual tablet versus commercial Imitrex® sumatriptan oral tablet in 14 healthy volunteers.
Detailed description
Volunteers will randomly receive either the commercial oral tablet 100 mg Imitrex® or 75 mg Omexa sublingual tablet under fasted conditions. One week following the first administration, the volunteers will receive the alternative treatment.
Blood samples will be collected at each visit before drug administration and at 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min after drug administration, in order to characterize the drug's absorption and pharmacokinetics, as well as to evaluate Omexa formulation safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 75 mg Omexa sumatriptan sublingual tablet | Experimental | Drug: Omexa Sublingual Sumatriptan tablet |
| 100 mg Imitrex oral tablet | Active comparator | Drug: Imitrex Oral Product |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Able to provide written informed consent
- Man and women volunteers 18-55 years of age
- Healthy with no clinically relevant abnormalities in the opinion of the investigator as determined by medical history, physical examination, urine analysis and vital signs.
- Have a BMI of 18-32 kg/m2, inclusive, and a body weight of not less than 50 kg
- Women of child-bearing potential who agree to use double contraceptive 14 days prior to the study, during whole duration of the study and 30 days after completion of the study.
Key exclusion criteria (22 listed)
- Pregnant or breast-feeding women (women of child bearing potential must use double contraceptive and have the results of a negative pregnancy test recorded prior to study drug administration)
- Have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Volunteers with two or more risk factors for ischemic heart disease
- History of seizures
- History of moderate to severe hypertension or mild uncontrolled hypertension or systolic blood pressure above 140 or diastolic above 90 during screening visit
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 |
|---|---|---|
| Omexa Sublingual Sumatriptan tablet75 mg | Drug | 75 mg Omexa sumatriptan sublingual tablet |
| Imitrex Oral ProductAlso: Sumatriptan100 mg | Drug | 100 mg Imitrex oral tablet |
Primary outcome
Time to reach peak plasma concentration (Tmax)
Time frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Peak Plasma concentration (Cmax)
Time frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
Area under the curve (AUC)
Time frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose
1 secondary outcome
Adverse events
Time frame: Through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- 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 Omexa Sublingual Sumatriptan tablet and Imitrex Oral Product in people with Migraine, run by Targia Pharmaceuticals Ltd..
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 22 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 3 Nov 2016. 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?
Time to reach peak plasma concentration (Tmax) (time frame: Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose). The study lists 3 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 3 Nov 2016; AzTrials last refreshed its copy on 4 Nov 2026.