/ CompletedNot Applicable [Translation] Human bioequivalence study of mirtazapine hydrochloride tablets
本试验旨在研究单次空腹口服宁波美诺华天康药业有限公司研制、生产的盐酸米那普仑片(50 mg)的药代动力学特征;以旭化成ファーマ株式会社(旭化成制药株式会社)持证、生产的盐酸米那普仑片(Toledomin®,50 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of mirtazapine hydrochloride tablets (50 mg) developed and manufactured by Ningbo Minova Tiankang Pharmaceutical Co., Ltd., after a single oral fasting dose. Minapril hydrochloride tablets (Toledomin®, 50 mg) manufactured by Asahi Kasei Corporation (Asahi Kasei Pharmaceutical Co., Ltd.) were used as the reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.
/ CompletedNot Applicable [Translation] Bioequivalence study of melogabalin besylate tablets in humans
本试验旨在研究单次空腹和餐后口服宁波美诺华天康药业有限公司研制、生产的苯磺酸美洛加巴林片(5 mg)的药代动力学特征;以DAIICHI SANKYO CO., LTD.持证、TAIYO Pharma Tech CO., LTD., Takatsuki Plant生产的苯磺酸美洛加巴林片(德力静®/Tarlige®,5 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of melogabalin besylate tablets (5 mg) developed and manufactured by Ningbo Minova Tiankang Pharmaceutical Co., Ltd., after a single fasting and postprandial oral administration. Melogabalin besylate tablets (Tarlige®, 5 mg), licensed by DAIICHI SANKYO CO., LTD. and manufactured by TAIYO Pharma Tech CO., LTD., Takatsuki Plant, were used as the reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.
/ Not yet recruitingEarly Phase 1IIT A Study on the Efficacy and Safety of Probiotic Capsule Products in Controlling Body Fat (Not a Substitute for Staple Foods)
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