Evaluation of gender difference in pharmacokinetics of Candesartan cilexetil in the fasted state by RP-HPLC: A single dose comparative study

Pak J Pharm Sci. 2019 May;32(3):1019-1024.

Abstract

To compare the pharmacokinetics of candesartan cilexetil in healthy male and female volunteers in order to identify possible influence of gender and to improve therapeutic outcomes, an HPLC method for the quantification of candesartan cilexetil was developed and validated. Total of 16 volunteers (8 male and 8 female) were registered. Candesartan cilexetil 16 mg was administered orally to all the volunteers and blood samples were collected at different time intervals between 0-72 hours. Plasma was separated and analysed by HPLC method. Pharmacokinetic parameters were calculated by using APO software MW/PHARM version 3.02 and compared in male and female volunteers. The developed HPLC method fulfils the criteria for linearity, accuracy and precision described in EMA guideline. The values for absorption rate constant (Ka), maximum plasma concentration (Cmax), volume of distribution (Vd) and Clearance (CL) were similar in male and female volunteers. No influence of gender was observed on overall pharmacokinetics of candesartan cilexetil. Therefore, no need for dose optimization while administering candesartan cilexetil in male and female patients was found based on the results of this study.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / blood*
  • Antihypertensive Agents / pharmacokinetics*
  • Benzimidazoles / administration & dosage
  • Benzimidazoles / blood*
  • Benzimidazoles / pharmacokinetics*
  • Biphenyl Compounds / administration & dosage
  • Biphenyl Compounds / blood*
  • Biphenyl Compounds / pharmacokinetics*
  • Chromatography, High Pressure Liquid / methods*
  • Chromatography, Reverse-Phase / methods
  • Female
  • Humans
  • Male
  • Reproducibility of Results
  • Sex Factors
  • Tetrazoles / administration & dosage
  • Tetrazoles / blood*
  • Tetrazoles / pharmacokinetics*
  • Young Adult

Substances

  • Antihypertensive Agents
  • Benzimidazoles
  • Biphenyl Compounds
  • Tetrazoles
  • candesartan cilexetil