主要目的：采用单中心、随机、开放、单剂量、三周期部分重复交叉空腹给药及四周期完全重复交叉餐后给药设计，比较山东新华制药股份有限公司提供的布洛肾素片（规格：布洛芬200mg/盐酸去氧肾上腺素10mg）与GlaxoSmithKline Consumer Healthcare Holdings（US）LLC持证的原研布洛肾素片（商品名：Advil Congestion Relief®，规格：布洛芬200 mg/盐酸去氧肾上腺素10 mg）在健康人群中吸收程度和速度的差异。次要目的：评价空腹及餐后条件下，山东新华制药股份有限公司提供的布洛肾素片（规格：布洛芬200mg/盐酸去氧肾上腺素10 mg）与GlaxoSmithKline Consumer Healthcare Holdings（US）LLC持证的原研布洛肾素片（商品名：Advil Congestion Relief®，规格：布洛芬200 mg/盐酸去氧肾上腺素10 mg）的安全性和耐受性。

[Translation]

Main purpose: A single-center, randomized, open, single-dose, three-cycle partial repeated crossover fasting administration and four-cycle complete repeated crossover meal administration design were used to compare the differences in absorption degree and speed of ibuprofen tablets (specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) provided by Shandong Xinhua Pharmaceutical Co., Ltd. and the original ibuprofen tablets (trade name: Advil Congestion Relief®, specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) certified by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC in healthy people. Secondary objective: To evaluate the safety and tolerability of ibuprofen tablets (specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) provided by Shandong Xinhua Pharmaceutical Co., Ltd. and original ibuprofen tablets (trade name: Advil Congestion Relief®, specifications: ibuprofen 200 mg/phenylephrine hydrochloride 10 mg) licensed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC under fasting and postprandial conditions.

Start Date25 Oct 2023

Sponsor / Collaborator

Shandong Xinhua Pharmaceutical Co., Ltd.

CTR20220033

/ CompletedNot Applicable

单中心、随机、开放、两制剂、三周期、部分重复交叉设计评价中国健康受试者单次空腹口服布洛芬去氧肾上腺素片的人体生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, three-period, partially repeated crossover design study to evaluate the bioequivalence of a single fasting oral dose of ibuprofen-phenylephrine tablets in healthy Chinese subjects

主要目的：以Pfizer公司生产的布洛芬去氧肾上腺素片(Advil® Congestion Relief，200mg：10mg)为参比制剂，以康芝药业股份有限公司生产的布洛芬去氧肾上腺素片(200mg：10mg)为受试制剂，通过单中心、随机、开放、三周期、部分重复交叉的临床试验设计，评价两种制剂在中国健康受试者空腹条件下的生物等效性。次要目的：评价受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Using Advil® Congestion Relief (200mg: 10mg) produced by Pfizer as the reference preparation and Ibuprofen Phenylephrine Tablets (200mg: 10mg) produced by Kangzhi Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, three-period, partially repeated crossover clinical trial design was conducted to evaluate the bioequivalence of the two preparations under fasting conditions in healthy Chinese subjects. Secondary purpose: Evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date27 May 2022

Sponsor / Collaborator

Honz Pharmaceutical Co., Ltd.

CTR20220034

/ CompletedNot Applicable

单中心、随机、开放、两制剂、四周期、完全重复交叉设计评价中国健康受试者单次餐后口服布洛芬去氧肾上腺素片的人体生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, four-period, completely repeated crossover design study to evaluate the bioequivalence of a single postprandial oral dose of ibuprofen-phenylephrine tablets in healthy Chinese subjects

主要目的：以Pfizer公司生产的布洛芬去氧肾上腺素片(Advil® Congestion Relief，200mg：10mg)为参比制剂，以康芝药业股份有限公司生产的布洛芬去氧肾上腺素片(200mg：10mg)为受试制剂，通过单中心、随机、开放、四周期、完全重复交叉的临床试验设计，评价两种制剂在中国健康受试者餐后条件下的生物等效性。次要目的：评价受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Using Advil® Congestion Relief (200mg: 10mg) produced by Pfizer as the reference preparation and Ibuprofen Phenylephrine Tablets (200mg: 10mg) produced by Kangzhi Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, four-period, completely repeated crossover clinical trial design was conducted to evaluate the bioequivalence of the two preparations under postprandial conditions in healthy Chinese subjects. Secondary purpose: Evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date01 Mar 2022

Sponsor / Collaborator

Honz Pharmaceutical Co., Ltd.

100 Clinical Results associated with Ibuprofen/Phenylephrine Hydrochloride

100 Translational Medicine associated with Ibuprofen/Phenylephrine Hydrochloride

100 Patents (Medical) associated with Ibuprofen/Phenylephrine Hydrochloride

100 Deals associated with Ibuprofen/Phenylephrine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	R05X	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Common Cold	AU	Johnson & Johnson Pacific Pty Ltd.	27 Aug 2009
Influenza, Human	AU	Johnson & Johnson Pacific Pty Ltd.	27 Aug 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis