Bioequivalence study of a fixed dose combination of irbesartan/amlodipine/hydrochlorothiazide film coated tablet manufactured in Turkey Türkiye’de üretilen irbesartan/amlodipin/hidroklorotiyazid film tablet sabit doz kombinasyonunun biyoeşdeğerlik çalişmasi


Uslu A., Dikmen İ., Köktürk M., Ünlü S., Ünsalan S., Çakıcı İ., ...More

Nobel Medicus, vol.10, no.3, pp.24-31, 2014 (SCI-Expanded) identifier

  • Publication Type: Article / Article
  • Volume: 10 Issue: 3
  • Publication Date: 2014
  • Journal Name: Nobel Medicus
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.24-31
  • Keywords: Amlodipine, Bioequivalence, Drug combination, Hydrochlorothiazide, Hypertension, Irbesartan
  • Istanbul Medipol University Affiliated: No

Abstract

Objective: The current study was designed to compare the pharmacokinetic properties and tolerability of the newly developed fixed dose combination (FDC) tablet of NOBEL [Irbesartan plus Amlodipine plus Hydrochlorothiazide (HCTZ), Film-coated Tablet, at doses 300 mg/10 mg/12.5 mg], respectively, with those of the conventional tablets of the marketed innovator formulations, CoAprovel 300 mg/12.5 mg Comprimés Pelliculés from Sanofi/Aventis-France and Norvasc 10 mg Tabletten from Pfizer bv Holland, administrated concomitantly in healthy male subjects. Material and Method: 36 subjects were randomly assigned into two groups according to a computer-generated randomization scheme. The subjects in group 1 received the reference formulations in period 1 and the test formulation in period 2, and those in group 2 vice versa, with a 21-day washout period between periods 1 and 2. Totally 23 blood sample points were selected including predose. The determination of amlodipine, irbesartan and HCTZ were performed using a validated high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) in lithium heparinised human plasma. Results: Pharmacokinetic findings showed that the newly developed FDC tablet of Nobel was bioequivalent to the marketed innovator formulations in healthy population under the studied conditions. Conclusion: Results indicated that the new FDC formulation of Nobel can be used interchangeably with the conventional formulations of the innovators.