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

NCT02954276 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-11-03

No results posted yet for this study

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

Interventions

DRUG

Omexa Sublingual Sumatriptan tablet

75 mg

DRUG

Imitrex Oral Product

100 mg

Sponsors & Collaborators

  • SoluBest Ltd.

    collaborator INDUSTRY

  • Targia Pharmaceuticals Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-08-31
Completion
2016-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954276 on ClinicalTrials.gov