[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of methylprednisolone tablets (4 mg) in healthy Chinese volunteers after meal administration

主要研究目的：按有关生物等效性试验的规定，选择 Pfizer Italia s.r.l 为持证商事的甲泼尼龙片（商品名： MEDROL；规格： 4mg）为参比制剂，对濮阳市汇元药业有限公司生产并提供的受试制剂甲泼尼龙片（规格： 4mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂甲泼尼龙片（规格： 4mg）和参比制剂甲泼尼龙片（商品名： MEDROL；规格： 4mg）的安全性。

[Translation]

Main purpose of study: According to the provisions of the relevant bioequivalence test, Pfizer Italia s.r.l. is selected as the reference preparation for the licensed commercial methylprednisolone tablets (trade name: MEDROL; specification: 4mg), and the test preparation methylprednisolone tablets (specification: 4mg) produced and provided by Puyang Huiyuan Pharmaceutical Co., Ltd. are used for postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under postprandial administration conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation methylprednisolone tablets (specification: 4mg) and the reference preparation methylprednisolone tablets (trade name: MEDROL; specification: 4mg) in healthy subjects.

Start Date25 Feb 2023

Sponsor / Collaborator

PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

CTR20223196

/ CompletedPhase 4

甲泼尼龙片（4mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效试验临床研究方案

主要研究目的：按有关生物等效性试验的规定，选择 Pfizer Italia s.r.l 为持证商的甲泼尼龙片（商品名：MEDROL；规格：4mg）为参比制剂，对濮阳市汇元药业有限公司生产并提供的受试制剂甲泼尼龙片（规格：4mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂甲泼尼龙片（规格：4mg）和参比制剂甲泼尼龙片（商品名：MEDROL；规格：4mg）的安全性。

[Translation]

Main study purpose: According to the relevant provisions of bioequivalence test, methylprednisolone tablets (trade name: MEDROL; specification: 4mg) with Pfizer Italia s.r.l as the licensee were selected as the reference preparation, and the test preparation methylprednisolone tablets (specification: 4mg) produced and provided by Puyang Huiyuan Pharmaceutical Co., Ltd. were conducted on the human bioequivalence test of fasting administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation methylprednisolone tablets (specification: 4mg) and the reference preparation methylprednisolone tablets (trade name: MEDROL; specification: 4mg) by healthy subjects.

Start Date30 Dec 2022

Sponsor / Collaborator

PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

CTR20180551

/ Active, not recruitingNot Applicable

吲达帕胺片在中国健康成年受试者的生物等效性研究

[Translation] Bioequivalence study of indapamide tablets in healthy adult subjects in China

主要目的：评价濮阳市汇元药业有限公司生产的吲达帕胺片（规格：2.5mg/片）与Les Laboratoires Servier生产的吲达帕胺片（规格：2.5mg/片）在健康成年受试者空腹情况下单次口服给药的人体生物等效性。次要目的：评价吲达帕胺片在健康成年受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of indapamide tablets (2.5 mg/tablet) produced by Puyang Huiyuan Pharmaceutical Co., Ltd. and indapamide tablets (2.5 mg/tablet) produced by Les Laboratoires Servier in healthy adult subjects after single oral administration on an empty stomach. Secondary objective: To evaluate the safety of indapamide tablets in healthy adult subjects.

Start Date14 Apr 2018

Sponsor / Collaborator

PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

100 Clinical Results associated with PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

0 Patents (Medical) associated with PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

100 Deals associated with PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

100 Translational Medicine associated with PUYANG HUIYUAN PHARMACEUTICAL CO., LTD.

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