SAFETY, TOLERABILITY AND BIOEQUIVALENCE ASSESSMENT OF ELETRIPTAN 40 mg TABLET

Atreyee Sarkar; Dr. Shivanand Dhanure

Volume : VI, Issue : VIII, August - 2017

SAFETY, TOLERABILITY AND BIOEQUIVALENCE ASSESSMENT OF ELETRIPTAN 40 mg TABLET

Atreyee Sarkar, Dr. Shivanand Dhanure

Abstract :

Eletriptan is a drug used to treat acute migraine. It acts as a 5-Hydroxytryptamine receptor agonist and is clinically effective for the treatment of migraine. Micro Labs is a generic drug company who had developed an Eletriptan 40 mg tablet formulation. The formulated tablets were tested in healthy adult human volunteers under fasting and fed conditions for bioequivalence as per United States (US) guideline for conduct of bioequivalence studies. The Reference product considered for bioequivalence was RELPAX^� of Pfizer. The formulation developed by Micro Labs was safe and well tolerated without major Adverse Events and was found to be bioequivalent to the reference drug formulation.