[Translation] A randomized controlled clinical study on the efficacy and safety of guaiac pseudoephedrine hydrocodone oral solution in the treatment of cough and other symptoms

以愈酚伪麻待因口服溶液为对照，评价愈酚伪麻氢可酮口服溶液治疗由普通感冒和流行性感冒引起的咳嗽且伴有鼻塞、多痰、流涕、喷嚏等症状的有效性和安全性

[Translation]

To evaluate the efficacy and safety of guaiac-pseudo-ephedrine-hydrocodone oral solution in the treatment of cough caused by the common cold and influenza with symptoms such as nasal congestion, sputum, runny nose, and sneezing, using guaiac-pseudo-ephedrine-hydrocodone oral solution as a control.

Start Date17 Sep 2013

Sponsor / Collaborator

Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

[+1]

CTR20130149 / CompletedPhase 1

愈酚伪麻氢可酮口服溶液人体药代动力学试验

[Translation] Pharmacokinetics of guaiac-pseudoephedrine-hydrocodone oral solution in humans

进行本品的药代试验，测定主要成分经时血药和尿药浓度，估算其主要药代参数，了解本品在健康人体内的ADME规律，与愈酚伪麻口服溶液进行药代对比试验，为制定本品II期临床试验方案提供依据，为临床用药的给药剂量依据。

[Translation]

Conduct pharmacokinetic tests on this product, determine the time-dependent blood and urine concentrations of the main ingredients, estimate its main pharmacokinetic parameters, understand the ADME laws of this product in healthy humans, and conduct pharmacokinetic comparison tests with guaiac-pseudoephedrine oral solution to provide a basis for formulating the Phase II clinical trial plan for this product and provide a basis for the dosage of clinical medication.

Start Date22 Jun 2013

Sponsor / Collaborator

Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.

[+1]

100 Clinical Results associated with Guaifenesin/Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride

100 Translational Medicine associated with Guaifenesin/Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride

100 Patents (Medical) associated with Guaifenesin/Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride

100 Deals associated with Guaifenesin/Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Common Cold	Phase 2	CN	Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.	22 Jun 2013
Common Cold	Phase 2	CN	Sichuan Antimicrobial Industry Research Institute	22 Jun 2013
Influenza, Human	Phase 2	CN	Sichuan Antimicrobial Industry Research Institute	22 Jun 2013
Influenza, Human	Phase 2	CN	Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.	22 Jun 2013
Sinusitis	Phase 2	CN	Sichuan Antimicrobial Industry Research Institute	22 Jun 2013
Bronchitis	Discovery	CN	Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.	22 Jun 2013
Bronchitis	Discovery	CN	Sichuan Antimicrobial Industry Research Institute	22 Jun 2013
Sinusitis	Discovery	CN	Shenzhen Zhijun Pharmaceutical Trade Co., Ltd.	22 Jun 2013

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