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Mechanism5-HT1A receptor agonists |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date29 Sep 1986 |
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Mechanismβ1-adrenergic receptor antagonists |
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Originator Org.- |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Austria |
First Approval Date17 Jan 1983 |
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MechanismTubulin inhibitors |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ RecruitingNot Applicable [Translation] Study on bioequivalence of finerenone tablets in healthy volunteers
本试验旨在研究健康研究参与者单次空腹和餐后口服北大医药股份有限公司研制、生产的非奈利酮片(10 mg)的药代动力学特征;以Bayer AG生产的非奈利酮片(可申达®,10 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of single fasting and postprandial oral administration of finerenone tablets (10 mg) developed and produced by Peking University Pharmaceutical Co., Ltd. in healthy study participants; finerenone tablets (Cosenta®, 10 mg) produced by Bayer AG were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared.
/ Active, not recruitingNot Applicable [Translation] Study on the bioequivalence of isavuconazole sulfate capsules in healthy volunteers
本试验旨在研究单次空腹和餐后口服北大医药股份有限公司研制、生产的硫酸艾沙康唑胶囊(100 mg)的药代动力学特征;以Pfizer Australia Pty Ltd持证的硫酸艾沙康唑胶囊(康新博®,100 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-72,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of isavuconazole sulfate capsules (100 mg) developed and produced by Peking University Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Isavuconazole sulfate capsules (Kangxinbo®, 100 mg) licensed by Pfizer Australia Pty Ltd were used as the reference preparation. The pharmacokinetic parameters Cmax and AUC0-72 of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of tofacitinib citrate sustained-release tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服北大医药股份有限公司研制、生产的枸橼酸托法替布缓释片(11 mg)的药代动力学特征;以Pfizer Inc.持证、Viatris Pharmaceuticals LLC生产的枸橼酸托法替布缓释片(Xeljanz®,11 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 aims to study the pharmacokinetic characteristics of tofacitinib citrate sustained-release tablets (11 mg) developed and produced by Peking University Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; tofacitinib citrate sustained-release tablets (Xeljanz®, 11 mg) licensed by Pfizer Inc. and produced by Viatris Pharmaceuticals LLC were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the human bioequivalence of the two preparations.
100 Clinical Results associated with PKU HealthCare Corp., Ltd.
0 Patents (Medical) associated with PKU HealthCare Corp., Ltd.
100 Deals associated with PKU HealthCare Corp., Ltd.
100 Translational Medicine associated with PKU HealthCare Corp., Ltd.