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NP101 Sumatriptan Iontophoretic Patch

Phase 1

Migraine Disorders | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Last Updated: Feb 3, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

NP101 Sumatriptan Iontophoretic Patch · 1 trial · 1 indication

Phase 1 1
NCT00720018Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy VolunteersMigraine Disorders
COMPLETED4 Analytics
PHASE1COMPLETED
Phase I Open Label Single-Dose Study to Compare the Pharmacokinetics of NP101 Healthy Volunteers
Migraine Disorders
NCT007200184
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Study Endpoints

Primary Endpoints

The primary objective was to compare the pharmacokinetics (PK) profiles among five NP101 patches in healthy volunteers.
Blood samples were collected at time points: pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 16 hrs post-dose.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTALNP101 Patch
Period 2EXPERIMENTALNP101 Patch
Period 3EXPERIMENTALNP101 Patch
Period 4EXPERIMENTALNP101 Patch
Period 5EXPERIMENTALNP101 Patch

Interventions

NameTypeDescription
NP101 Sumatriptan Iontophoretic Transdermal PatchDRUGNP101 transdermal patch delivering sumatriptan for 4 hours.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Caucasian men or women aged 18 to 45. * Subjects have BMI of 18 to 30 kg/m2 inclusive. * Subject judged to be in good health, based upon the results of a medical history, physical examination, vital signs, ECG and laboratory profile. Subjects will not have any clinical...

Countries:United States
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Frequently asked questions about NP101 Sumatriptan Iontophoretic Patch

What is NP101 Sumatriptan Iontophoretic Patch used for?

NP101 Sumatriptan Iontophoretic Patch is an investigational small molecule being developed for the treatment of migraine disorders. It is a sumatriptan patch designed to deliver the medication through the skin using iontophoresis. The drug is currently in Phase 1 clinical development and is not yet approved for use.

Who makes NP101 Sumatriptan Iontophoretic Patch?

NP101 Sumatriptan Iontophoretic Patch is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. Teva is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational migraine treatment.

What phase is NP101 Sumatriptan Iontophoretic Patch in?

NP101 Sumatriptan Iontophoretic Patch is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and how the body processes it. One Phase 1 study has been completed.

What clinical trials is NP101 Sumatriptan Iontophoretic Patch in?

NP101 Sumatriptan Iontophoretic Patch has one completed clinical trial, registered as NCT00720018. This was a Phase 1 open-label, single-dose study that compared the pharmacokinetics of NP101 in healthy volunteers. The study enrolled 4 participants in the United States and was a controlled trial.

Is NP101 Sumatriptan Iontophoretic Patch the same as sumatriptan?

NP101 Sumatriptan Iontophoretic Patch contains sumatriptan, a well-known migraine medication, but it is a specific formulation delivered via an iontophoretic patch. This patch system is designed to deliver sumatriptan through the skin using a mild electrical current. It is an investigational product being developed by Teva.