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Eletriptan commercial

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 28, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Eletriptan commercial · 1 trial · 1 indication

Phase 1 1
NCT01139515Eletriptan Pharmacokinetics In Korean MalesHealthy
COMPLETED16 Analytics
PHASE1COMPLETED
Eletriptan Pharmacokinetics In Korean Males
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)

AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

AUC From Time Zero to Last Quantifiable Concentration (AUClast)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

Maximum Observed Plasma Concentration (Cmax)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)

Secondary Endpoints

Time to Reach Maximum Observed Plasma Concentration (Tmax)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
Plasma Decay Half Life (t1/2)
Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTAL1 X 20 mg eletriptan
Treatment BEXPERIMENTAL1 X 40 mg eletriptan
Treatment CEXPERIMENTAL2 X 40 mg eletriptan
Treatment DEXPERIMENTAL1 X 40 mg tablet given 2 hr after initial 1 X 40 mg tablet dose

Interventions

NameTypeDescription
Eletriptan commercial tabletDRUG20 mg tablet, single dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male subjects, 18-55 years old * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 * provide informed consent Exclusion Criteria: * blood pressure \>140/90 mm Hg * any condition possibly affecting drug absorption * positive urine drug screen

Countries:South Korea
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Frequently asked questions about Eletriptan commercial

What is Eletriptan commercial used for?

Eletriptan commercial is a small molecule being studied for use in healthy individuals. It is currently in Phase 1 clinical development, with one completed trial focused on its pharmacokinetics in healthy Korean males. The drug is being developed by Pfizer, Inc. (PFE).

Who makes Eletriptan commercial?

Eletriptan commercial is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical research on this small molecule, which is currently in Phase 1 development for use in healthy individuals.

What phase is Eletriptan commercial in?

Eletriptan commercial is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for its pharmacokinetics in healthy volunteers. One Phase 1 trial has been completed, involving 16 participants.

What clinical trials is Eletriptan commercial in?

Eletriptan commercial has one completed clinical trial, NCT01139515, titled 'Eletriptan Pharmacokinetics In Korean Males.' This Phase 1 study enrolled 16 healthy male participants in South Korea, with a minimum age of 18 years. The trial was controlled but not double-blind.

Is Eletriptan commercial the same as Eletriptan?

Eletriptan commercial is a formulation of eletriptan, a small molecule being studied by Pfizer. The 'commercial' designation likely refers to the commercial-grade version of the drug. It is currently in Phase 1 development for healthy individuals, with one completed pharmacokinetic trial.