Pharmacokinetics and bioequivalence study of a generic amlodipine tablet formulation in healthy male volunteers

Sailer R., Arnold P., Erenmemisoglu A., Martin W., Tamur U., Kanzik I., ...More

ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH, vol.57, no.7, pp.462-466, 2007 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 57 Issue: 7
  • Publication Date: 2007
  • Doi Number: 10.1055/s-0031-1296632
  • Journal Name: ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.462-466
  • Hacettepe University Affiliated: No

Abstract

Two different tablets containing amlodipine besylate (CAS 111470-99-6) (Vazkorl((R)) 10 mg tablet as test preparation and 10 mg tablet of the originator product as reference preparation) were investigated in 18 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence between both treatments after oral single dose administration. The study was performed according to an open-label, randomized, two-period cross-over design with a wash-out phase of 21 days.