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MechanismMAO-B inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date21 Feb 2005 |
/ Not yet recruitingPhase 1 甲磺酸雷沙吉兰透皮贴剂在中国健康受试者中单、多次给药的安全性、药代动力学和药效动力学特征以及与甲磺酸雷沙吉兰片的PK/PD特征比较研究
[Translation] Safety, pharmacokinetic and pharmacodynamic characteristics of single and multiple administrations of rasagiline mesylate transdermal patch in Chinese healthy subjects and comparison of PK/PD characteristics with rasagiline mesylate tablets
第一部分:PK/PD探索研究
1)评价甲磺酸雷沙吉兰透皮贴剂给药一周(4天/贴+3天/贴)的安全性。
2)评价甲磺酸雷沙吉兰透皮贴剂给药一周(4天/贴+3天/贴)的药代动力学和药效动力学特征。
3)比较甲磺酸雷沙吉兰透皮贴剂与甲磺酸雷沙吉兰片的药代动力学和药效动力学特征。
4)评价甲磺酸雷沙吉兰透皮贴剂给药后的黏附性、刺激性和致敏性。
第二部分:多次给药生物利用度研究
1)比较甲磺酸雷沙吉兰透皮贴剂与甲磺酸雷沙吉兰片在健康人体内连续给药的相对生物利用度。
2)比较甲磺酸雷沙吉兰透皮贴剂与甲磺酸雷沙吉兰片多次给药的药效动力学特征。
3)评价甲磺酸雷沙吉兰透皮贴剂和甲磺酸雷沙吉兰片多次给药的安全性。
4)评价甲磺酸雷沙吉兰透皮贴剂多次给药的黏附性、刺激性和致敏性。
第三部分:不同部位生物利用度研究
1)比较甲磺酸雷沙吉兰透皮贴剂不同部位给药的生物利用度。
2)评价甲磺酸雷沙吉兰透皮贴剂的安全性、黏附性、刺激性和致敏性。
[Translation] Part I: PK/PD Exploratory Study
1) Evaluate the safety of rasagiline mesylate transdermal patch for one week (4 days/patch + 3 days/patch).
2) Evaluate the pharmacokinetic and pharmacodynamic characteristics of rasagiline mesylate transdermal patch for one week (4 days/patch + 3 days/patch).
3) Compare the pharmacokinetic and pharmacodynamic characteristics of rasagiline mesylate transdermal patch and rasagiline mesylate tablets.
4) Evaluate the adhesion, irritation and sensitization of rasagiline mesylate transdermal patch after administration.
Part II: Multiple-dose bioavailability study
1) Compare the relative bioavailability of rasagiline mesylate transdermal patch and rasagiline mesylate tablets after continuous administration in healthy humans.
2) Compare the pharmacodynamic characteristics of rasagiline mesylate transdermal patch and rasagiline mesylate tablets after multiple administration.
3) Evaluate the safety of multiple administration of rasagiline mesylate transdermal patch and rasagiline mesylate tablets.
4) Evaluate the adhesion, irritation and sensitization of multiple administration of rasagiline mesylate transdermal patch.
Part III: Bioavailability study at different sites
1) Compare the bioavailability of rasagiline mesylate transdermal patch at different sites.
2) Evaluate the safety, adhesion, irritation and sensitization of rasagiline mesylate transdermal patch.
100 Clinical Results associated with Shanghai Shiling Pharmaceutical Co., Ltd.
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