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Outline
To evaluate the bioequivalence and safety of dexlansoprazole sustained-release capsule in healthy subjects on fasting and postprandial state.
A random, open, four-cycle, two-cross and single-dose design was adopted. Healthy subjects were grouped to either fasting or postprandial group (n=30 in each group). The concentrations of lansoprazole at 15 different time points after oral test or reference preparation (Dexilant®) were determined by high-performance liquid chromatography-tandem mass spectrometry. Average bioequivalence (ABE) method was adopted. The bioequivalence was evaluated using mixed effect model by Phoenix WinNonlin (Pharsight Corporation, Version 6.4) and confidence interval method. Adverse events (AE) were monitored during the whole test.
Thirty subjects completed the test in each of fasting or postprandial group. The average age of the subjects was 38.90±10.31 in fasting group, the ratio of male to female was 1∶1.31. The geometric average ratios of tested Cmax, AUC0-t and AUC0-∞ were 102.44%, 103.20% and 103.09%, and the 90% confidence intervals were 93.92%~111.74%, 98.57%~108.03% and 98.32%~108.09%, respectively. The average age of the subjects was (41.30±11.12) years in postprandial group, and the ratio of male to female was 1∶1.50, with the standard deviation Swr of each individual less than 0.294. The geometric average ratios of Cmax, AUC0-t and AUC0-∞ were 101.04%, 101.83% and 101.49%, with the 90% confidence intervals 95.76%~106.60%, 98.43%~105.35% and 97.90%~105.22%, respectively. The most common AE (≥2%) occurred during the experiment mainly included diarrhea, abdominal pain, and nausea. The unanticipated AE correlated with the test were T wave lowland (4, 6.67%), urine ketone body raised (1, 1.67%) and tachycardia (1, 1.67%). All AEs were not treated and recovered to normal. No serious adverse events (SAE) occurred.
Two formulations of dexlansoprazole sustained release capsules are bioequivalent and safe.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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