[Translation] A single-center, randomized, open-label, single-dose, two-period, crossover bioequivalence study of acetaminophen and dihydrocodeine tablets in Chinese healthy subjects under fasting and fed conditions

主要目的：以持证商为Accord UK Ltd的氨酚双氢可待因片(商品名：Co-dydramol®，规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为参比制剂，以陕西九州制药有限责任公司研究生产的氨酚双氢可待因片(规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为受试制剂，通过单中心、随机、开放、单剂量、双周期、交叉试验设计，评价两制剂在健康受试者空腹和餐后状态下单次口服给药的人体生物等效性。次要目的：观察及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 the acetaminophen and dihydrocodeine tablets (trade name: Co-dydramol®, specifications: acetaminophen 500 mg, dihydrocodeine tartrate 10 mg) produced by Accord UK Ltd as the reference preparation, and the acetaminophen and dihydrocodeine tablets (specifications: acetaminophen 500 mg, dihydrocodeine tartrate 10 mg) developed and produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-period, crossover trial design was used to evaluate the bioequivalence of the two preparations in healthy subjects in the fasting and postprandial state after a single oral administration. Secondary purpose: Observe and evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date05 Aug 2023

Sponsor / Collaborator

Shaanxi Jiuzhou (Group) Pharmaceutical Industry Co.

CTR20231820 / RecruitingNot Applicable

单中心、随机、开放、单剂量、双周期、交叉试验设计评价中国健康受试者空腹和餐后口服氨酚双氢可待因片的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period, crossover study to evaluate the bioequivalence of fasting and fed oral acetaminophen and dihydrocodeine tablets in healthy Chinese subjects

以持证商为Accord UK Ltd的氨酚双氢可待因片(商品名：Co-dydramol®，规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为参比制剂，以陕西九州制药有限责任公司研究生产的氨酚双氢可待因片(规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为受试制剂，通过单中心、随机、开放、单剂量、双周期、交叉试验设计，评价两制剂在健康受试者空腹和餐后状态下单次口服给药的人体生物等效性。

[Translation]

Using the Paracetamol and Dihydrocodeine Tablets (trade name: Co-dydramol®, specifications: 500 mg paracetamol and 10 mg dihydrocodeine tartrate) produced by Accord UK Ltd as the reference preparation and the Paracetamol and Dihydrocodeine Tablets (specifications: 500 mg paracetamol and 10 mg dihydrocodeine tartrate) developed and produced by Shaanxi Jiuzhou Pharmaceutical Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-period, crossover study was conducted to evaluate the bioequivalence of the two preparations after single oral administration in healthy subjects under fasting and fed conditions.

Start Date09 Jun 2023

Sponsor / Collaborator

Shaanxi Jiuzhou (Group) Pharmaceutical Industry Co.

IRCT20230221057473N1 / RecruitingPhase 1/2IIT

Comparison of the effect of two drugs acetaminophen codeine and Anahil in combination with acetaminophen codeine on pain relief in patients needing dental implants after implant surgery

Start Date30 Apr 2023

Sponsor / Collaborator

Shiraz University of Medical Sciences

100 Clinical Results associated with Acetaminophen/Dihydrocodeine Tartrate

100 Translational Medicine associated with Acetaminophen/Dihydrocodeine Tartrate

100 Patents (Medical) associated with Acetaminophen/Dihydrocodeine Tartrate

Literatures (Medical) associated with Acetaminophen/Dihydrocodeine Tartrate

01 Dec 2021·Journal of Orthopaedic Surgery and ResearchQ3 · MEDICINE

A retrospective analysis of the effects of different analgesics on the pain of patients with traumatic thoracolumbar fractures in the peri-treatment period

Q3 · MEDICINE

ArticleOA

Author: Wen, Song ; Xiong, Liu-Lin ; Li, Ting-Ting ; Chen, Jie ; Wang, Ya-Ting ; Yuan, Hao ; Gan, Zong-Jin ; Chang, Quan-Yuan

AbstractObjectiveTo analyze and compare the effects of peri-treatment analgesics on acute and chronic pain and postoperative functional recovery of patients with thoracolumbar fractures, so as to guide the clinical drug use.MethodsSeven hundred nineteen patients with thoracolumbar fractures were collected and divided into acetaminophen dihydrocodeine, celecoxib, and etoricoxib groups. The main indicators were the degree of postoperative pain (visual analog scale (VAS)), the incidence of chronic pain and postoperative functional recovery (Oswestry dysfunction index (ODI) and Japanese Orthopedics Association score (JOA)), which were continuously tracked through long-term telephone follow-up. The correlation analysis of ODI-pain score, peri-treatment VAS score, and ODI index was performed, and bivariate regression analysis was conducted to understand the risk factors for chronic pain.ResultsRegression analysis showed that severe spinal cord injury and peri-treatment use of acetaminophen dihydrocodeine were both one of the risk factors for postoperative chronic pain. But there were no statistically conspicuous differences in basic characteristics, preoperative injury, and intraoperative conditions. Compared with the other two groups, patients in the acetaminophen dihydrocodeine group had longer peri-therapeutic analgesic use, higher pain-related scores (VAS 1 day preoperatively, VAS 1 month postoperatively, and ODI-pain 1 year postoperatively), higher VAS variation, higher incidence of chronic pain 1 year after surgery, and higher ODI index. And other ODI items and JOA assessments showed no statistically significant differences. In addition, the correlation analysis showed that the peri-treatment pain score was correlated with the severity of postoperative chronic pain.ConclusionAlthough the peri-treatment analgesic effect of acetaminophen dihydrocodeine is good, it is still necessary to combine analgesics with different mechanisms of action for patients with severe preoperative pain of thoracolumbar fracture, so as to inhibit the incidence of postoperative chronic pain and improve the quality of postoperative rehabilitation.

100 Deals associated with Acetaminophen/Dihydrocodeine Tartrate

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R&D Status

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Indication	Country/Location	Organization	Date
Pain	CN	Weihai Lutan Pharmaceutical Co. Ltd.	27 Aug 2003

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02647788 (CTgov)	Phase 4	Pain, Postoperative	144	Acetaminophen/Ibuprofen (Acetaminophen/Ibuprofen)	xfpkvoiuaf(pmtdjfxvsm) = knojahsofb elyrepsaqa (khgsyjvwjv, xfpqkvpszj - sdoxjxjbtl) View more	-	18 Feb 2019
				Acetaminophen/Codeine (Acetaminophen/Codeine)	xfpkvoiuaf(pmtdjfxvsm) = djsrlssgue elyrepsaqa (khgsyjvwjv, cddogcgwbj - ikrdqpkuoo) View more

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