Dataset Information

Bioequivalence of two tablet formulations of cefpodoxime proxetil in beagle dogs.

ABSTRACT: The pharmacokinetic profiles and bioequivalence of two cefpodoxime proxetil tablets were investigated in Beagle dogs. A single-dose, four-way complete replication and crossover design was used in the present study. A total of 28 healthy Beagle dogs (half male and female) with an average body weight of 11.1 kg were randomly allocated to this study. A whole reference or test tablet containing the equivalent of 100 mg of cefpodoxime was administered orally to each dog. Serial plasma samples were collected, and cefpodoxime concentrations were determined by ultra-performance liquid chromatography-mass spectrometry (UPLC-MS/MS). Then a non-compartmental method was used to calculate the pharmacokinetic parameters of both tablet formulations. The average bioequivalence (ABE) or reference-scaled average bioequivalence (RSABE) methods were used to determine the 90% confidence interval (CI) of AUC_{INF_obs} and C_max. No significant differences were observed for both parameters between both tablets. The test formulation was bioequivalent to the reference one because the 90% CI ranges of C_max and AUC_{INF_obs} were all between 80 and 125%.

SUBMITTER: Gao YY

PROVIDER: S-EPMC9614231 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Bioequivalence of two tablet formulations of cefpodoxime proxetil in beagle dogs.

Gao Yan-Yan YY Sang Ka-Na KN Li Peng-Peng PP Hao Jie J Zhang Cong C Li Huan-Juan HJ Zhou De-Gang DG

Frontiers in veterinary science 20221014

The pharmacokinetic profiles and bioequivalence of two cefpodoxime proxetil tablets were investigated in Beagle dogs. A single-dose, four-way complete replication and crossover design was used in the present study. A total of 28 healthy Beagle dogs (half male and female) with an average body weight of 11.1 kg were randomly allocated to this study. A whole reference or test tablet containing the equivalent of 100 mg of cefpodoxime was administered orally to each dog. Serial plasma samples were co ...[more]

PMID: 36311679

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Project description:Background and objectiveA novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the same delivered dose (10 µg/actuation). This study describes the pharmacokinetic bioequivalence to the reference product.MethodsThis randomized, two-stage, crossover, semi-replicate (three-way) study was performed in healthy volunteers. In each study period, subjects received a single dose of two capsules (20 μg delivered dose) of the study medication, separated by a 14-day washout period: tiotropium 10 μg delivered dose (Laboratorios Liconsa, Spain) and Spiriva HandiHaler(®) (Boehringer Ingelheim Pharma GmbH & Co KG, Germany). Blood samples were obtained up to 48 h post-dose to evaluate the comparative bioavailability. Tiotropium was measured in plasma by means of dual stage liquid-liquid extraction followed by the two-dimensional ultra-high performance liquid chromatography sensitive sub-pg/mL bioanalytical method. The main pharmacokinetic parameters were maximum plasma concentration (C max), area under the concentration-time curve (AUC) from time zero hours to the last observed concentration at time t (AUC t ), and AUC from time zero hours to 30 min (AUC0.5). Bioequivalence was accepted if the 90.20 % confidence interval (CI) for the ratio test/reference of the primary pharmacokinetic parameters lay within the acceptance range of 80-125 %. Safety assessment was a secondary endpoint.ResultsA total of 30 subjects were randomized and bioequivalence was demonstrated for all primary pharmacokinetic parameters: C max (CI 87.26-106.60 %), AUC t (CI 101.33-111.64 %), and AUC0.5 (CI 97.95-113.49 %). Both study treatments were well tolerated (four non-serious adverse events [AEs] were reported in four subjects: one AE before any product administration, two AEs after test product administration; and one AE after reference product administration).ConclusionsBoth products containing tiotropium 10 µg delivered-dose DPI were bioequivalent and showed good tolerability and a similar safety profile.

Dataset Information

Bioequivalence of two tablet formulations of cefpodoxime proxetil in beagle dogs.

Publications

Bioequivalence of two tablet formulations of cefpodoxime proxetil in beagle dogs.

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