Single-dose oral bioequivalence study of Primaquine 15 mg tablet (test product) and Primaquine 15 mg tablet (reference product) in healthy adult human subjects under fasting conditions

Abstract

WHO prequalification offers the possibility of a line extension based on demonstrating proportionality with the adult 15 mg tablet. For a generic manufacturer, a bioequivalence study must be performed comparing the generic (test) product with the reference 15 mg of primaquine. This study is to establish the bioequivalence of a new scored 15 mg generic PQ tablet, produced by IPCA in India.