Comparative Bioavailability Study of Omexa Sumatriptan vs. Imitrex® in Healthy Volunteers

NCT02954276 | Unknown Phase 1

• 2 other identifiers: SB17050189-15-WOMC
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Migraine

Keywords

safety

Outcome Measures

Primary Outcomes (3)

• Time to reach peak plasma concentration (Tmax)

  Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose

• Peak Plasma concentration (Cmax)

  Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose

• Area under the curve (AUC)

  Predose, 5, 15, 30, 45, 60, 90, 120, 240, 360 and 480 min post-dose

Secondary Outcomes (1)

• Adverse events

  Through study completion, an average of 2 months

Study Arms (2)

75 mg Omexa sumatriptan sublingual tablet

EXPERIMENTAL

Drug: Omexa Sublingual Sumatriptan tablet

100 mg Imitrex oral tablet

ACTIVE COMPARATOR

Drug: Imitrex Oral Product

Interventions

Omexa Sublingual Sumatriptan tablet DRUG

75 mg

75 mg Omexa sumatriptan sublingual tablet

Imitrex Oral Product DRUG

100 mg

Also known as: Sumatriptan

100 mg Imitrex oral tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Targia Pharmaceuticals Ltd.: lead
• SoluBest Ltd.: collaborator

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 3, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share