The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions

Fırat Yerlikaya

Makale detayları

The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions

Yazarlar:

Fırat Yerlikaya

Yayıncı:

Hacettepe University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.43-49

Belge Tipi:

Makale

Yayın Tarihi:

1/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001284501

pISSN:

2458-8806

Anahtar kelimeler:

Özet:

 A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice GCP principles. Two 250 mg5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MSMS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.

 A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice GCP principles. Two 250 mg5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MSMS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.

 A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice GCP principles. Two 250 mg5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MSMS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.

 A new liquid oral formulation of cefdinir has been developed and a bioequivalence study was conducted. This single-center study was designed as an open-label, randomized, two-period, cross-over trial, and was performed with healthy males under fasting conditions in compliance with Good Clinical Practice GCP principles. Two 250 mg5mL suspension formulation of cefdinir was compared in terms of their pharmacokinetic properties and the bioequivalence of the new formulation was assessed according to the requirement of the authorities. The blood samples of the volunteers were taken at certain points specified to cefdinir, to evaluate the plasma concentrations and pharmacokinetic properties of two cefdinir formulations by using a validated LC-MSMS analytical method. The bioequivalence of the new formulation has been shown and the tolerability of both products was acceptable.

Makale detayları

The Bioequivalence Study of Two Cefdinir 250 mg/5 mL Oral Suspension Formulations in Healthy Males Under Fasting Conditions

Yazarlar:

Fırat Yerlikaya

Yayıncı:

Hacettepe University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.43-49

Belge Tipi:

Makale

Yayın Tarihi:

1/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001284501

pISSN:

2458-8806

bioequivalence

cefdinir

cephalosporin

GCP

bioequivalance

cefdinir

cephalosporin

GCP

Sayı

Makale detayları

Yazarlar: Fırat Yerlikaya

Yayıncı: Hacettepe University

Ana Başlıklar: Pharmacology and Pharmaceutical Sciences

Dergi: Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.43-49

Belge Tipi: Makale

Yayın Tarihi: 1/2023

Belge Dili: İngilizce

Document ID (Org No.): 2001284501

pISSN: 2458-8806

Sayı

Yazarlar:

Fırat Yerlikaya

Yayıncı:

Hacettepe University

Ana Başlıklar:

Pharmacology and Pharmaceutical Sciences

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy Vol.43 Issue 1, pp.43-49

Belge Tipi:

Makale

Yayın Tarihi:

1/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001284501

pISSN:

2458-8806