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Bioequivalence of Sarpogrelate in Healthy Chinese Subjects Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Investigation by a Reference-Scaled Average Bioequivalence Approach
Copyright policy )WileyBioequivalence of Sarpogrelate in Healthy Chinese Subjects Under Fasting and Fed Conditions: A 4-Way Replicate Crossover Investigation by a Reference-Scaled Average Bioequivalence Approach
Sarpogrelate is widely used to treat peripheral vascular disorders. However, it has been demonstrated to have a poor pharmacokinetic (PK) profile and marked within-subject variability. Here, the bioequivalence of 2 formulations of sarpogrelate (100-mg tablets) was assessed by using the reference-scaled average bioequivalence (RSABE) method, and the PK parameters were quantified in healthy Chinese subjects under fasting (n = 38) and fed (n = 35) conditions. In this open and randomized 4-way replicate study, a single dose of sarpogrelate was administered followed by a 3-day washout period. The sarpogrelate concentration in blood samples was measured by liquid chromatography-tandem mass spectrometry within 6 hours (fasting) or 10 hours (fed) of drug administration, and the PK parameters were determined by a noncompartmental model. The bioequivalence of the 2 formulations under both conditions was assessed using the ratios of ln(peak concentration [Cmax ]) and ln(area under the concentration-time curve [AUC]) within the limits based on the RSABE method. The 90% CIs for the ratios of lnCmax , lnAUC0-t , and lnAUC0-∞ were 0.8531-1.1100, 0.9616-1.0737, and 0.9550-1.0684, respectively, under fasting conditions and 0.8918-1.1076, 0.9818-1.0694, and 0.9818-1.0686, respectively, under fed conditions, which were within the RSABE acceptance limits. Food intake decreased the systemic exposure and the Cmax of sarpogrelate by 0.9-fold and 0.5-fold, respectively.
- Jilin University China (People's Republic of)
Microsoft Academic Graph classification: Medicine business.industry business Bioequivalence Replicate Sarpogrelate chemistry.chemical_compound chemistry PK Parameters Cmax Pharmacology Pharmacokinetics Chinese subjects Peak concentration
Pharmacology (medical), Pharmaceutical Science, Adult, Biological Availability, China, Cross-Over Studies, Drug Compounding, Drugs, Generic, Fasting, Food-Drug Interactions, Humans, Male, Middle Aged, Succinates, Therapeutic Equivalency, Young Adult
Pharmacology (medical), Pharmaceutical Science, Adult, Biological Availability, China, Cross-Over Studies, Drug Compounding, Drugs, Generic, Fasting, Food-Drug Interactions, Humans, Male, Middle Aged, Succinates, Therapeutic Equivalency, Young Adult
Microsoft Academic Graph classification: Medicine business.industry business Bioequivalence Replicate Sarpogrelate chemistry.chemical_compound chemistry PK Parameters Cmax Pharmacology Pharmacokinetics Chinese subjects Peak concentration
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).3 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).3 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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- Jilin University China (People's Republic of)
Sarpogrelate is widely used to treat peripheral vascular disorders. However, it has been demonstrated to have a poor pharmacokinetic (PK) profile and marked within-subject variability. Here, the bioequivalence of 2 formulations of sarpogrelate (100-mg tablets) was assessed by using the reference-scaled average bioequivalence (RSABE) method, and the PK parameters were quantified in healthy Chinese subjects under fasting (n = 38) and fed (n = 35) conditions. In this open and randomized 4-way replicate study, a single dose of sarpogrelate was administered followed by a 3-day washout period. The sarpogrelate concentration in blood samples was measured by liquid chromatography-tandem mass spectrometry within 6 hours (fasting) or 10 hours (fed) of drug administration, and the PK parameters were determined by a noncompartmental model. The bioequivalence of the 2 formulations under both conditions was assessed using the ratios of ln(peak concentration [Cmax ]) and ln(area under the concentration-time curve [AUC]) within the limits based on the RSABE method. The 90% CIs for the ratios of lnCmax , lnAUC0-t , and lnAUC0-∞ were 0.8531-1.1100, 0.9616-1.0737, and 0.9550-1.0684, respectively, under fasting conditions and 0.8918-1.1076, 0.9818-1.0694, and 0.9818-1.0686, respectively, under fed conditions, which were within the RSABE acceptance limits. Food intake decreased the systemic exposure and the Cmax of sarpogrelate by 0.9-fold and 0.5-fold, respectively.