Effect of Food on the Pharmacokinetics of Desvenlafaxine in Healthy Subjects

Nichols, Alice I.; Richards, Lyette S; Behrle, J. A.; Posener, Joel A.; Paul, Jeffrey

doi:10.4172/jbb.1000106

Cited by 4 publications

(9 citation statements)

References 19 publications

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“…These findings are consistent with a study for assessment of Desvenlafaxine succinate pharmacokinetic changes when administered with or without food and that did not report significant changes in the molecule Bioavailability when interacting with food in the intestine [4]. The obtained values for C max and AUC 0-t either for the Test and Reference products are similar to those obtained in other studies [17].…”

Section: Discussionsupporting

confidence: 81%

“…The lowest increase of peak plasma concentration in high fat content conditions was not clinically relevant [4]. In our study, there was no effect in the mean T max extension for both products following a regular Colombian diet.…”

Section: Women Menmentioning

confidence: 55%

“…Nichols et al [4] reported a Desvenlafaxine T max of approximately 6 hours in fasting conditions and approximately 2 to 4 additional hours when administered with food without affecting the apparent elimination half-life of oral dose except for the peak mean plasma concentration reached in postprandial conditions with a high fat content [4]. The lowest increase of peak plasma concentration in high fat content conditions was not clinically relevant [4].…”

Section: Women Menmentioning

confidence: 99%

“…It has linear kinetics in the 100 to 600 mg/day range, although its antidepressant efficacy has been demonstrated with 50 mg/day doses. Its oral Bioavailability is 80% and it is not modified by low fat meals [4,5]. It is mainly metabolized by glucuronidation through UDP-glucuronyltransferase and to a lesser extent through the cytochrome CYP3A4 oxidative pathway.…”

Section: Introductionmentioning

confidence: 99%

“…It was approved in 2008 by the FDA for the Major Depressive Disorder (MDD) treatment given its short-term safety, tolerability and demonstrated efficacy in placebo-controlled trials [1][2][3]. In its succinate salt form, an extended active ingredient release is produced, allowing the administration of one tablet every 24 hours since it has a plasma concentration peak at 6 to 8 hours in fasting conditions (8 to 10 hours if taken postprandial) and an elimination half-life between 9 to 15 hours [4,5]. It has linear kinetics in the 100 to 600 mg/day range, although its antidepressant efficacy has been demonstrated with 50 mg/day doses.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Jba¹

2014

J Bioequiv Availab

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Section: Discussionsupporting

confidence: 81%

Section: Women Menmentioning

confidence: 55%

Section: Women Menmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Jba¹

2014

J Bioequiv Availab

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A Review of Current Methods for Food Effect Prediction During Drug Development

Zhang

Wells

2020

Curr Pharmacol Rep

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Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado – 50 mg comprimido revestido de liberação prolongada – administradas em jejum e pós-prandial em voluntários sadios de ambos os sexos

Predrazzoli-Júnior¹,

Calafati²,

Coelho³

et al. 2017

JBES

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Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado -50 mg comprimido revestido de liberação prolongadaadministradas em jejum e pós-prandial em voluntários sadios de ambos os sexos Cada estudo foi conduzido de maneira independente, sendo ambos do tipo aberto, dois períodos, utilizando um delineamento do tipo crossover 2x2, envolvendo 48 voluntários, com intervalo de sete dias entre os períodos (washout). Resultados: Na administração em jejum, a razão entre a média geométrica da formulação teste e referência (T/R) de C máx foi 107,49%, com intervalo de confiança (IC) 90% de 100,81 a 114,60%. Para ASC 0-t , a razão T/R foi de 104,90%, com IC 90% de 97,53 a 112,82%. Na administração pós-prandial, a razão T/R de C máx foi 103,17%, com IC 90% de 95,08 a 111,94%. Para ASC 0-t , a razão T/R foi 103,40%, com IC 90% de 94,97 a 112,58%. Conclusões: As formulações teste e referência foram consideradas estatisticamente bioequivalentes em ambas as condições de administração, jejum e pós-prandial, de acordo com os critérios exigidos pela Agência Nacional de Vigilância Sanitária (Anvisa). A formulação teste foi o primeiro medicamento similar (Zodel®, 50 e 100 mg) registrado pela Anvisa nessa categoria e disponibilizado para comercialização, contribuindo assim com a ampliação da disponibilidade do tratamento para o transtorno depressivo maior e a redução de custos ao paciente. In the fasted administration, the ratio between the geometrical mean of test formulation and reference (T/R) of C max was 107.49%, with confidence interval 90% (CI 90%) of 100.81 to 114.60%. For AUC 0-t, the ratio T/R was of 104.90%, with CI 90% from 97.53% to 112.82%. In the fed administration, the ratio T/R of C max was 103.17% with CI 90% of 95.08 to 111.94%. For AUC 0-t, the ratio T/R was 103.40%, with CI 90% of 94.97 to 112.58%. Conclusions: The test and reference formulations were considered statistically bioequivalent in the two administration conditions, fasted and fed, according to the requirements of Brazilian National Health Surveillance Agency (Anvisa). The test formulation was the first similar medicine (Zodel®, 50 e 100 mg) to be registered by Anvisa in this category and available to commercialization, thus contributing to increase the availability of treatment for major depressive disorder and the reduction of costs to the patient.

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Effect of Food on the Pharmacokinetics of Desvenlafaxine in Healthy Subjects

Cited by 4 publications

References 19 publications

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

Bioequivalence Study of Two 50 mg Desvenlafaxine Extended Release Formulations: A Randomized, Single-Dose, Open-Label, Two Periods, Crossover Study

A Review of Current Methods for Food Effect Prediction During Drug Development

Avaliação da bioequivalência entre duas formulações de succinato de desvenlafaxina monoidratado – 50 mg comprimido revestido de liberação prolongada – administradas em jejum e pós-prandial em voluntários sadios de ambos os sexos

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