Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects
Abstract
OBJECTIVE: The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet versus a brand-named empagliflozin tablet (Jardiance®) and evaluate the food effects on the pharmacokinetics (PK) of empagliflozin in healthy Chinese subjects.
METHODS: Forty-eight healthy volunteers were included in this randomized, open-label, crossover, two-period study (fasting: n = 24, fed: n = 24). A single dose of 25-mg generic (or test) or brand-named (or reference) empagliflozin was administered to each subject in a randomized sequence. Blood samples were collected at the baseline and during the 72 h post-dose, and plasma empagliflozin concentrations were determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Pharmacokinetic parameters were analyzed with non-compartmental methods. Safety was monitored.
RESULTS: The major PK parameters including C max, AUC0- t , and AUC0-∞ were similar between the generic and brand-named tablets under fasting and fed conditions (all p > .05). The 90% confidence intervals of the test/reference ratios of log-transformed C max, AUC0- t , and AUC0-∞ were 94.90-106.70%, 100.62-106.99%, and 100.64-106.85%, respectively, under fasting condition, and 94.21-104.91%, 97.31-101.79%, and 97.32-101.83%, respectively, under fed condition. High-fat food did not affect C max, AUC0- t , AUC0-∞, or T max of empagliflozin (all p > .05). There was no serious adverse event during the study period.
CONCLUSION: The…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 24 participants or records.
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