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Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers
Copyright policy )Springer Science and Business Media LLCDrug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers
The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers. The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks. A rapid and simple LC–MS/MS method was developed and validated for the simultaneous estimation of SOF and LED using eplerenone as an internal standard (IS). The results showed that the 90% confidence intervals (CIs) for natural log-transformed ratios of Cmax, AUClast and AUC∞ of SOF (89.95–115.31, 98.77–109.75 and 98.79–109.75) were within the RSABE acceptance limits. The 90% CIs for natural log-transformed ratios of Cmax and AUClast of LED (87.33–115.15 and 83.82–112.26) were within the FDA bioequivalence limits (80.00–125.00). In addition, the in vitro dissolution study was done and both formulations released > 85% of drug within 15 min in the proposed dissolution medium. In conclusion, bioequivalence between the two fixed-dose combination products was demonstrated for both active ingredients.
Microsoft Academic Graph classification: Bioequivalence Pharmacokinetics Fixed-dose combination Crossover study Confidence interval Sofosbuvir medicine.drug medicine Chromatography Cmax Ledipasvir chemistry.chemical_compound chemistry business.industry business
Pharmacology (medical), General Medicine, Adolescent, Adult, Area Under Curve, Benzimidazoles, Chromatography, Liquid, Cross-Over Studies, Drug Compounding, Drug Therapy, Combination, Drugs, Generic, Egypt, Female, Fluorenes, Healthy Volunteers, Humans, Male, Middle Aged, Reference Standards, Sofosbuvir, Tablets, Tandem Mass Spectrometry, Therapeutic Equivalency, Young Adult
Pharmacology (medical), General Medicine, Adolescent, Adult, Area Under Curve, Benzimidazoles, Chromatography, Liquid, Cross-Over Studies, Drug Compounding, Drug Therapy, Combination, Drugs, Generic, Egypt, Female, Fluorenes, Healthy Volunteers, Humans, Male, Middle Aged, Reference Standards, Sofosbuvir, Tablets, Tandem Mass Spectrometry, Therapeutic Equivalency, Young Adult
Microsoft Academic Graph classification: Bioequivalence Pharmacokinetics Fixed-dose combination Crossover study Confidence interval Sofosbuvir medicine.drug medicine Chromatography Cmax Ledipasvir chemistry.chemical_compound chemistry business.industry business
citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).6 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).6 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average
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The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers. The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks. A rapid and simple LC–MS/MS method was developed and validated for the simultaneous estimation of SOF and LED using eplerenone as an internal standard (IS). The results showed that the 90% confidence intervals (CIs) for natural log-transformed ratios of Cmax, AUClast and AUC∞ of SOF (89.95–115.31, 98.77–109.75 and 98.79–109.75) were within the RSABE acceptance limits. The 90% CIs for natural log-transformed ratios of Cmax and AUClast of LED (87.33–115.15 and 83.82–112.26) were within the FDA bioequivalence limits (80.00–125.00). In addition, the in vitro dissolution study was done and both formulations released > 85% of drug within 15 min in the proposed dissolution medium. In conclusion, bioequivalence between the two fixed-dose combination products was demonstrated for both active ingredients.