Key result
The test and reference formulations of 8 mg candesartan cilexetil tablets were bioequivalent in healthy Chinese volunteers under fasting conditions, with 90% CIs for Cmax and AUC ratios falling entirely within the 80% to 125% range.
Why the study?
The study aimed to assess the pharmacokinetics and bioequivalence of a test formulation versus a reference formulation of candesartan cilexetil tablets in healthy Chinese volunteers.
Is the test formulation of candesartan cilexetil 8 mg bioequivalent to the reference formulation in healthy Chinese volunteers under fasting conditions?
RCT (n=48)
Open-label
Computer-generated random number table
No
Is the test formulation of candesartan cilexetil 8 mg bioequivalent to the reference formulation in healthy Chinese volunteers under fasting conditions?
The test formulation of candesartan cilexetil 8 mg is bioequivalent to the reference formulation in healthy Chinese volunteers under fasting conditions, with a good safety profile.
Provides PK/bioequivalence data in Chinese volunteers; leaves open interchangeability in clinical use.
Candesartan is an antihypertensive agent that acts on an angiotensin II receptor.Candesartan cilexetil is a prodrug that is converted into the active form of candesartan during intestinal absorption.This study aimed to assess the pharmacokinetics and bioequivalence of a reference and a test formulation of candesartan cilexetil tablets in healthy Chinese volunteers.A randomized, open-label, single-dose, crossover study was conducted with two treatment periods.Forty-eight healthy Chinese volunteers participated under fasted conditions.Qualified subjects were randomly divided into two groups (1:1 ratio) to receive either the test or reference formulation first.A washout period of 14 days separated the administration of the two formulations.Blood samples were collected at specific time points and analyzed for candesartan concentration using Ultra High-Performance Liquid Chromatography Tandem Mass Spectrometry (UPLC-MS/MS).The maximum concentration (C max ), the AUC from time zero to the last measured time point (AUC 0-t ) and the AUC from time zero to infinity (AUC 0-∞ ) fell within the bioequivalence range of 80% to 125%.These results suggest that the test and reference formulations of candesartan cilexetil tablets are bioequivalent, meaning they have similar rates and extents of absorption in healthy Chinese volunteers.No serious adverse events or side effects were reported throughout the study.
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Han et al. (2024) conducted an RCT in Healthy volunteers (n=48). Candesartan cilexetil test formulation vs. Candesartan cilexetil reference formulation was evaluated on Bioequivalence (Cmax least squares geometric mean) (T/R ratio 88.91%, 95% CI 82.98-95.28). The test and reference formulations of 8 mg candesartan cilexetil tablets were bioequivalent in healthy Chinese volunteers under fasting conditions, with 90% CIs for Cmax and AUC ratios falling entirely within the 80% to 125% range.
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