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

dc.contributor.author	Ethiopian Food and Drug Authority
dc.date.accessioned	2026-02-24T10:33:33Z
dc.date.available	2026-02-24T10:33:33Z
dc.date.issued	2024
dc.identifier.uri	http://repository.iphce.org/xmlui/handle/123456789/5362
dc.description.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.	en_US
dc.language.iso	en_US	en_US
dc.subject	Malaria	en_US
dc.title	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	en_US
dc.title.alternative	Primaquine bioequivalence study (PBE)	en_US
dc.type	Report	en_US