[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of bisoprolol amlodipine tablets (5mg/5mg) produced by Shandong Qidu Pharmaceutical Co., Ltd. and bisoprolol amlodipine tablets (Kangxinan®, 5mg/5mg) produced by Egis Pharmaceuticals Plc in healthy Chinese subjects under fasting and fed conditions

以山东齐都药业有限公司生产的比索洛尔氨氯地平片（规格：5 mg/5 mg）为受试制剂，以持证商为Merck Kft，生产商为Egis Pharmaceuticals Plc的比索洛尔氨氯地平片（康忻安®，规格：5 mg/5 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Bisoprolol Amlodipine Tablets (Specification: 5 mg/5 mg) produced by Shandong Qidu Pharmaceutical Co., Ltd. was used as the test preparation, and Bisoprolol Amlodipine Tablets (Kangxinan®, Specification: 5 mg/5 mg) produced by Merck Kft and Egis Pharmaceuticals Plc was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date13 Oct 2023

Sponsor / Collaborator

Shandong Qidu Pharmaceutical Co. Ltd.

CTR20231751 / CompletedNot Applicable

山东齐都药业有限公司生产的替米沙坦氨氯地平片（80 mg/5 mg）与Boehringer Ingelheim International GmbH上市的替米沙坦氨氯地平片（TWYNSTA®，80 mg/5 mg）在中国健康受试者中进行的随机、开放、单剂量、两序列、四周期、空腹状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fasting bioequivalence study of telmisartan amlodipine tablets (80 mg/5 mg) produced by Shandong Qidu Pharmaceutical Co., Ltd. and telmisartan amlodipine tablets (TWYNSTA®, 80 mg/5 mg) marketed by Boehringer Ingelheim International GmbH in healthy Chinese subjects

以山东齐都药业有限公司的替米沙坦氨氯地平片（80 mg/5 mg）为受试制剂，Boehringer Ingelheim International GmbH上市的替米沙坦氨氯地平片（TWYNSTA®，规格80 mg/5 mg）为参比制剂，考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性，同时评价两制剂在健康受试者中的安全性。

[Translation]

Telmisartan Amlodipine Tablets (80 mg/5 mg) produced by Shandong Qidu Pharmaceutical Co., Ltd. was used as the test preparation, and Telmisartan Amlodipine Tablets (TWYNSTA®, 80 mg/5 mg) produced by Boehringer Ingelheim International GmbH was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the fasting state were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.

Start Date13 Jun 2023

Sponsor / Collaborator

Shandong Qidu Pharmaceutical Co. Ltd.

CTR20230220 / CompletedNot Applicable

山东齐都药业有限公司生产的替米沙坦氨氯地平片（80 mg/5 mg）与Boehringer Ingelheim International GmbH上市的替米沙坦氨氯地平片（TWYNSTA®，80 mg/5 mg）在中国健康受试者中进行的随机、开放、单剂量、三周期、三序列、空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, three-period, three-sequence, fasting and fed bioequivalence study of Telmisartan Amlodipine Tablets (80 mg/5 mg) produced by Shandong Qidu Pharmaceutical Co., Ltd. and Telmisartan Amlodipine Tablets (TWYNSTA®, 80 mg/5 mg) marketed by Boehringer Ingelheim International GmbH in healthy Chinese subjects

以山东齐都药业有限公司的替米沙坦氨氯地平片（80 mg/5 mg）为受试制剂，Boehringer Ingelheim International GmbH 上市的替米沙坦氨氯地平片（TWYNSTA®，规格80 mg/5 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性，同时评价两制剂在健康受试者中的安全性。

[Translation]

Telmisartan Amlodipine Tablets (80 mg/5 mg) produced by Shandong Qidu Pharmaceutical Co., Ltd. was used as the test preparation, and Telmisartan Amlodipine Tablets (TWYNSTA®, 80 mg/5 mg) produced by Boehringer Ingelheim International GmbH was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.

Start Date26 Feb 2023

Sponsor / Collaborator

Shandong Qidu Pharmaceutical Co. Ltd.

100 Clinical Results associated with Shandong Qidu Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Shandong Qidu Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Shandong Qidu Pharmaceutical Co. Ltd.

01 Jun 2024·Journal of Reproductive Immunology

Associations between cytokines and the risk of female and male infertility: A two-sample Mendelian randomization analysis

Article

Author: Zhang, Jianwei ; Han, Letian ; Wu, Zhijuan ; Li, Honglin ; Zhang, Lei

PURPOSEObservational studies have linked cytokines to the occurrence of female and male infertility. However, it is not clear how biomarkers of inflammation are causally related to infertility. To explore whether genetic variants in circulating cytokines are associated with the pathogenesis of infertility, we performed two-sample Mendelian randomization (MR) analysis.METHODSA total of 31,112 individuals of European ancestry were included in a genome-wide association study (GWAS) of 47 circulating cytokines as instrumental variables (IVs). Outcome data were female infertility, including four different subtypes, and male infertility, from the FinnGen consortium. Five MR methods, including inverse-variance weighted (IVW), MR-Egger, simple mode, weighted median, and weighted mode were employed to examine the genetic association between cytokines and the risk of female infertility and male infertility. The false discovery rate (FDR) was controlled using the Benjamini-Hochberg method.RESULTSAfter FDR correction, cis-protein quantitative trait locus (cis-pQTL) instruments showed that the cytokines GROa and MCSF were positively associated with female infertility. In analyses of subtypes of female infertility, eotaxin and sICAM were inversely associated with ovulation-related infertility; MCP3 alone was positively associated with uterus-related infertility; GROa and MCSF were positively correlated with infertility of cervical, vaginal, and other or unspecified origin; and MIP1a was negatively correlated with tubal origin infertility. The cytokines HGF, IL-2ra, and RANTES were positively correlated with male infertility. Similar findings were obtained in sensitivity analyses. There was no evidence of pleiotropy or heterogeneity in the results.CONCLUSIONThese findings contribute to current understanding of the role of cytokine biomarkers in the etiology of female and male infertility. Furthermore clinical experimental validation is required to evaluate the potential of these cytokines as biomarkers.

30 Jun 2023·Molecules (Basel, Switzerland)

Icariin Promotes Osteogenic Differentiation in a Cell Model with NF1 Gene Knockout by Activating the cAMP/PKA/CREB Pathway.

Article

Author: Chen, Meng ; Cheng, Dong ; Zhang, Tianliang ; Liu, Xinyong ; Lu, Lianhua ; Zhang, Jing ; Zhang, Jianli

Neurofibromatosis type 1 is a rare autosomal dominant genetic disorder, with up to 50% of patients clinically displaying skeletal defects. Currently, the pathogenesis of bone disorders in NF1 patients is unclear, and there are no effective preventive and treatment measures. In this study, we found that knockout of the NF1 gene reduced cAMP levels and osteogenic differentiation in an osteoblast model, and icariin activated the cAMP/PKA/CREB pathway to promote osteoblast differentiation of the NF1 gene knockout cell model by increasing intracellular cAMP levels. The PKA selective inhibitor H89 significantly impaired the stimulatory effect of icariin on osteogenesis in the NF1 cell model. In this study, an osteoblast model of NF1 was successfully constructed, and icariin was applied to the cell model for the first time. The results will help to elucidate the molecular mechanism of NF1 bone disease and provide new ideas for the clinical prevention and treatment of NF1 bone disease and drug development in the future.

19 Apr 2022·Journal of Diabetes ResearchQ3 · MEDICINE

Prediction of Visual Acuity after anti-VEGF Therapy in Diabetic Macular Edema by Machine Learning

Q3 · MEDICINE

ArticleOA

Author: Zhai, Weibin ; Lin, Zhenzhe ; Xu, Fabao ; Huang, Chao ; Li, Jianqiao ; Wei, Min ; Zhang, Ying ; Wang, Jiawei

Purpose. To predict visual acuity (VA) 1 month after anti-vascular endothelial growth factor (VEGF) therapy in patients with diabetic macular edema (DME) by using machine learning. Methods. This retrospective study included 281 eyes with DME receiving intravitreal anti-VEGF treatment from January 1, 2019, to April 1, 2021. Eighteen features from electronic medical records and measurements data from OCT images were extracted. The data obtained from January 1, 2019, to November 1, 2020, were used as the training set; the data obtained from November 1, 2020, to April 1, 2021, were used as the validation set. Six different machine learning algorithms were used to predict VA in patients after anti-VEGF therapy. After the initial detailed investigation, we designed an optimization model for convenient application. The VA predicted by machine learning was compared with the ground truth. Results. The ensemble algorithm (linear regression + random forest regressor) performed best in VA and VA variance predictions. In the validation set, the mean absolute errors (MAEs) of VA predictions were 0.137-0.153 logMAR (within 7-8 letters), and the mean square errors (MSEs) were 0.033-0.045 logMAR (within 2-3 letters) for the 1-month VA predictions, respectively. For the prediction of VA variance at 1 month, the MAEs were 0.164-0.169 logMAR (within 9 letters), and the MSEs were 0.056-0.059 logMAR (within 3 letters), respectively. Conclusions. Our machine learning models could accurately predict VA and VA variance in DME patients receiving anti-VEGF therapy 1 month after, which would be much valuable to guide precise individualized interventions and manage expectations in clinical practice.

100 Deals associated with Shandong Qidu Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Shandong Qidu Pharmaceutical Co. Ltd.

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