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., ...Daha Fazla

ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH, cilt.57, sa.7, ss.462-466, 2007 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 57 Sayı: 7
  • Basım Tarihi: 2007
  • Doi Numarası: 10.1055/s-0031-1296632
  • Dergi Adı: ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.462-466
  • Hacettepe Üniversitesi Adresli: Hayır

Özet

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.