Overview

The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions

Status:
Completed

Trial end date:
2019-08-14

Target enrollment:

Participant gender:

Summary

This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of candesartan in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject received each study treatment in a crossover fashion, a control group was not included. Within the clinical portion of the study each subject received a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints were the pharmacokinetic (PK) parameters Cmax and AUC0-t of candesartan.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborators:

Altasciences Company Inc.
Altasciences Company, Inc.

Treatments:

Candesartan
Candesartan cilexetil