Delving into the Latest Updates on Hetero Phrma (Beijing) Co., Limited with Synapse

Overview

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test product, gefitinib tablets (strength: 250 mg), and the reference product (IRESSA®) (strength: 250 mg) in healthy adult subjects under fasting conditions

主要研究目的：研究空腹状态下单次口服受试制剂吉非替尼片（规格：250 mg，HETERO LABS LIMITED 生产）与参比制剂吉非替尼片（IRESSA®，规格：0.25 g，Kagamiishi Plant, Nipro Pharma Corporation 生产）在健康成年男性受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂吉非替尼片（规格：250 mg）和参比制剂吉非替尼片（IRESSA®，规格：0.25 g）在健康成年男性受试者中的安全性。

[Translation]

Primary study objective: To study the pharmacokinetics of a single oral dose of the test preparation gefitinib tablets (250 mg, manufactured by HETERO LABS LIMITED) and the reference preparation gefitinib tablets (IRESSA®, 0.25 g, manufactured by Kagamiishi Plant, Nipro Pharma Corporation) in healthy adult male subjects, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary study objective: To evaluate the safety of the test preparation gefitinib tablets (250 mg) and the reference preparation gefitinib tablets (IRESSA®, 0.25 g) in healthy adult male subjects.

Start Date-

Sponsor / Collaborator

Hetero Phrma (Beijing) Co., Limited

100 Clinical Results associated with Hetero Phrma (Beijing) Co., Limited

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