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Bioequivalence study of rotigotine patches in healthy Chinese subjects
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Min-sheng JIANG1, 2, Xian-miao YIN1, 2, Qi-tao ZHU1, 2, Yu HUA1, 2, Huan SONG1, 2, Feng DING1, 2, Dong-sheng GUO1, Fang-liang GAN1
Chinese Journal of Clinical Pharmacology | 2025, 41(6) : 852 - 856
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Chinese Journal of Clinical Pharmacology | 2025, 41(6): 852-856
• Pharmacokinetics and Bioequivalence Study •
Bioequivalence study of rotigotine patches in healthy Chinese subjects
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Min-sheng JIANG1, 2, Xian-miao YIN1, 2, Qi-tao ZHU1, 2, Yu HUA1, 2, Huan SONG1, 2, Feng DING1, 2, Dong-sheng GUO1, Fang-liang GAN1
Affiliations
  • 1.Office of Clinical Pharmacology, Xianning Central Hospital, Xianning 437100, Hubei Province, China
  • 2.School of Pharmacy, Faculty of Medicine, Hubei University of Science and Technology, Xianning 437100, Hubei Province, China
Published: 2025-03-28 doi: 10.13699/j.cnki.1001-6821.2025.06.019
Outline
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Objective

To evaluate the bioequivalence of rotigotine patches after a single dose in healthy Chinese subjects.

Methods

Using randomized, open, fasting, single-dose, two-preparation, four-cycle, two-sequence exact repeat crossover design, 24 healthy subjects applied one of the test preparation or reference preparation (4.5 mg·10 cm-2) to the abdominal skin. To determine the drug concentration in human plasma by liquid chromatography-tandem mass spectrometry. Pharmacokinetic software was used to calculate the relevant pharmacokinetic parameters, and the bioequivalence evaluation was carried out.

Results

The Cmax of the test preparation and the reference preparation of rotigotine patches were (275.04±98.93) and (277.11±96.78) pg·mL-1, the AUC0-t were (5 011.91±2 015.32) and (4 934.28±2 095.76) h·pg·mL-1, the AUC0-∞ were (5 092.68±2 033.23) and (5 160.61±2 052.04) h·pg·mL-1, respectively. Cmax, AUC0-t and AUC0-∞ geometric mean (90% confidence interval) were all in the equivalent interval of 80.00%-125.00%.

Conclusion

The test preparation and reference preparation of rotigotine patches are bioequivalent in healthy Chinese subjects.

rotigotine patches  /  liquid chromatography-tandem mass spectrometry  /  pharmacokinetic  /  bioequivalence
Min-sheng JIANG, Xian-miao YIN, Qi-tao ZHU, Yu HUA, Huan SONG, Feng DING, Dong-sheng GUO, Fang-liang GAN. Bioequivalence study of rotigotine patches in healthy Chinese subjects[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (6) : 852 -856 . DOI: 10.13699/j.cnki.1001-6821.2025.06.019
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Year 2025 volume 41 Issue 6
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.06.019
  • Receive Date：2024-10-10
  • Online Date：2026-08-04
  • Published：2025-03-28
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History
  • Received：2024-10-10
Affiliations
    1.Office of Clinical Pharmacology, Xianning Central Hospital, Xianning 437100, Hubei Province, China
    2.School of Pharmacy, Faculty of Medicine, Hubei University of Science and Technology, Xianning 437100, Hubei Province, China
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表12种不同金属材料的力学参数
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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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