[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of cefcapone hydrochloride granules in healthy subjects

以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂盐酸头孢卡品酯颗粒（规格：50mg（按C17H19N5O6S2计），持证商：苏州盛达药业有限公司）与参比制剂盐酸头孢卡品酯颗粒（规格：50mg（按C17H19N5O6S2计），持证商：SHIONOGI & Co., LTD.）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。

[Translation]

Pharmacokinetic parameters were used as the primary endpoint evaluation indicators. The pharmacokinetic behaviors of the test preparation Cefcapone Hydrochloride Granules (Specification: 50 mg (calculated as C17H19N5O6S2), license holder: Suzhou Shengda Pharmaceutical Co., Ltd.) and the reference preparation Cefcapone Hydrochloride Granules (Specification: 50 mg (calculated as C17H19N5O6S2), license holder: SHIONOGI & Co., LTD.) in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations.

Start Date31 Jul 2024

Sponsor / Collaborator

China Union Chempharma (Suzhou) Co., Ltd.

CTR20192349

/ RecruitingNot Applicable

盐酸头孢卡品酯颗粒在中国健康受试者中随机、开放、空腹及餐后、单剂量、两周期、双交叉的生物等效性试验

[Translation] A randomized, open-label, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of cefcapone hydrochloride granules in Chinese healthy subjects

①主要目的：通过随机、开放、空腹及餐后、单剂量、两周期、双交叉的生物等效性试验以药代动力学参数为终点评价指标，评估受试制剂和参比制剂在空腹/餐后条件下给药时的相对生物利用度和生物等效性。 ②次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

①Main purpose: To evaluate the relative bioavailability and bioequivalence of the test preparation and the reference preparation under fasting/postprandial conditions through a randomized, open, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study with pharmacokinetic parameters as the endpoint evaluation indicators. ②Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date30 Dec 2019

Sponsor / Collaborator

Zhongshan Bailing Biotechnology Co., Ltd.

CTR20131706

/ RecruitingPhase 2

多中心、随机、双盲双模拟、平行对照临床研究评价盐酸头孢卡品酯颗粒治疗急性细菌感染的有效性和安全性

[Translation] A multicenter, randomized, double-blind, double-dummy, parallel controlled clinical study to evaluate the efficacy and safety of cefcapone hydrochloride granules in the treatment of acute bacterial infections

以头孢泊肟酯片为对照药，对桂林南药股份有限公司开发的盐酸头孢卡品酯颗粒进行临床研究，评价其临床疗效及安全性

[Translation]

Using cefpodoxime axetil tablets as the control drug, a clinical study was conducted on cefpodoxime hydrochloride granules developed by Guilin Pharmaceutical Co., Ltd. to evaluate its clinical efficacy and safety

Start Date04 Dec 2013

Sponsor / Collaborator

Guilin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Cefcamate Pivoxil Hydrochloride

100 Translational Medicine associated with Cefcamate Pivoxil Hydrochloride

100 Patents (Medical) associated with Cefcamate Pivoxil Hydrochloride

Literatures (Medical) associated with Cefcamate Pivoxil Hydrochloride

01 Jan 2025·Biomedicine & Pharmacotherapy

Oral administration of Bifidobacterium longum and Bifidobacterium infantis ameliorates cefcapene pivoxil-induced attenuation of anti-programmed cell death protein-1 antibody action in mice

Article

Author: Wada, Satoshi ; Udaka, Yuko ; Uchiyama, Jun ; Tsunoda, Takuya ; Nakano, Ryota ; Tajima, Kohei ; Kuramasu, Atsuo ; Nobe, Koji ; Maruyama, Yuki ; Oguchi, Tatsunori ; Yoshimura, Kiyoshi ; Amari, Yasunobu ; Yamazaki, Yoshitaka ; Akiyama, Masahiro ; Hosonuma, Masahiro ; Sasaki, Akiko ; Toyoda, Hitoshi ; Shida, Midori ; Funayama, Eiji ; Kiuchi, Yuji ; Sasaki, Aya ; Kim, Yun-Gi ; Sambe, Takehiko ; Tsuji, Mayumi ; Baba, Yuta ; Murayama, Masakazu ; Tsurui, Toshiaki ; Nakashima, Rie ; Kobayashi, Shinichi ; Isobe, Junya ; Narikawa, Yoichiro

Gut bacteria play pivotal roles in the antitumor effects of immune checkpoint inhibitors (ICIs). However, antimicrobial therapy, often necessary for infections in cancer patients, can reduce the efficacy of ICIs. The potential of probiotics to restore ICI efficacy remains uncertain. This study evaluated the effects of Bifidobacterium longum and Bifidobacterium infantis (BLBI) in a CT-26 subcutaneous tumor mouse model treated with anti-programmed cell death protein 1 antibody (αPD-1) and cefcapene pivoxil (CFPN-PI). BALB/c mice received daily oral gavage of CFPN-PI for 5 days before tumor inoculation, followed by weekly αPD-1 administration and tumor growth monitoring. BLBI was administered via ad libitum feeding, mixed in powdered feed. Gut microbiota composition and fecal short-chain fatty acid concentrations were assessed, along with gene expression and immune cell populations in the tumor microenvironment, using quantitative RT-PCR and flow cytometry, respectively. CFPN-PI alone increased tumor growth and attenuated the antitumor effect of αPD-1. In contrast, BLBI inhibited CFPN-PI-induced tumor growth and improved the efficacy of αPD-1. Probiotic treatment increased the stool propionic acid concentration and the number of tumor-infiltrating conventional type 1 dendritic cells. Relative decreases in Bacteroides and Lachnospiraceae _NK4A136_group species and relative increases in Muribaculaceae and Unclassified_f_Oscillospiraceae species correlated with an improved αPD-1 response. These results suggest that probiotic administration may be a new therapeutic strategy to rescue the attenuated efficacy of ICIs in patients with cancer who require antimicrobial therapy.

13 Jul 2024·Biological and Pharmaceutical Bulletin

Assessment of the Safety of Exposure to Cefcapene Pivoxil during the First Trimester of Pregnancy: A Prospective Cohort Study in Japan

Article

Author: Taogoshi, Takanori ; Miki, Yosuke ; Murashima, Atsuko ; Hishinuma, Kayoko ; Matsuo, Hiroaki ; Yakuwa, Naho ; Yokooji, Tomoharu ; Goto, Mikako ; Koga, Yuki ; Itamura, Ryo

Cefcapene pivoxil hydrochloride is an antibiotic often used by women who are or may be pregnant. However, the safety of exposure to it during the first trimester of pregnancy has not been assessed. In this study, we aimed to clarify the effects of exposure during the first trimester of pregnancy on maternal and fetal outcomes. Data were obtained from pregnant women who were counseled on drug use during pregnancy at two Japanese facilities from April 1988 to December 2017. The incidence of major malformations in singleton pregnancy was compared between neonates born to women who took cefcapene pivoxil hydrochloride (n = 270) and control drugs (n = 1594) during their first trimester. The adjusted odds ratio of the incidence of major malformations was calculated using multivariate logistic regression analysis adjusted for smoking during pregnancy and maternal age. The incidence of major malformations was 2.6% in the cefcapene pivoxil hydrochloride group and 1.8% in the control group. There were no significant differences in the incidence between the cefcapene pivoxil hydrochloride and control groups (adjusted odds ratio: 1.48 [95% confidence interval: 0.64-3.42], p = 0.36). This prospective cohort study showed that exposure to cefcapene pivoxil hydrochloride during the first trimester of pregnancy was not associated with increased risk of major malformations in infants. Our findings will help healthcare providers in choosing appropriate medicines.

01 Apr 2024·Auris Nasus Larynx

Efficacy, safety, and tissue penetration of solithromycin in Japanese patients with otorhinolaryngological infections

Article

Author: Kurono, Yuichi ; Suzuki, Kenji ; Watanabe, Akira ; Shimada, Satoshi ; Kudo, Fumiyo ; Yamatake, Takahiro

OBJECTIVETo assess the efficacy, safety, and tissue penetration of solithromycin for the treatment of otorhinolaryngological infections, we conducted three studies: a tissue penetration study with patients scheduled to undergo otorhinolaryngological tissue removal, an open-label study comprising patients with otitis media, pharyngitis, laryngitis, and tonsillitis, and a non-inferiority study compared with high-dose cefcapene-pivoxil (CFPN-PI).METHODSTissue penetration study; 17 patients with chronic rhinosinusitis, chronic otitis media, chronic tonsillitis, or palatine tonsillar hypertrophy, who required resection or removal of their tissue, were enrolled. Solithromycin was administered orally, and otorhinolaryngological tissues were collected 3.5-6 h after drug administration; blood was collected within 15 min before and after drug administration. The collected tissues and blood concentrations were measured at a central laboratory. Open-label study; 55 patients who were diagnosed with acute otitis media, laryngopharyngitis, or tonsillitis were enrolled. Solithromycin was administered orally 800 mg on Day 1, while on days 2-7, 400 mg of the drug was administered once daily. The primary endpoint is the clinical response at Test-of-Cure (TOC: 5-10 days after completion) Non-inferiority study; 283 patients with acute rhinosinusitis or acute exacerbation of chronic rhinosinusitis were randomized into either the solithromycin group or CFPN-PI group. Solithromycin was administered 800 mg once daily on Day 1 and 400 mg once daily while on Days 2-7 in solithromycin group, and CFPN-PI was administered 150 mg three times a day while on Days 1-7 in CFPN-PI group. The primary endpoint is the clinical response at TOC.RESULTSIn the tissue penetration study, the tissue concentration ratios (tissue concentration/plasma concentration) of solithromycin were 4.19 in the sinonasal mucosa, 1.33 in the middle ear mucosa, and 6.12 in the palatine tonsil tissue. In the open-label study, the efficacy rates at the TOC were 97.0 % for acute otitis media, 100 % for laryngopharyngitis, and 81.8 % for tonsillitis. In the non-inferiority study comprising patients with rhinosinusitis, the efficacy rate at the TOC was 87.7 % for solithromycin and 89.7 % for CFPN-PI. The difference in the efficacy rate (95 % confidence interval) was -2.0 % (-9.4 % to 5.4 %), verifying the non-inferiority of solithromycin to CFPN-PI. The most common adverse events in patients administered solithromycin were diarrhea (20.7 %), nausea and nasopharyngitis (3.6 %,), pharyngitis and elevated hepatic function test results (3.1 %), and abnormal hepatic function (2.1 %).CONCLUSIONBased on the findings, it is suggested that solithromycin is useful for the treatment of otorhinolaryngological infections.

100 Deals associated with Cefcamate Pivoxil Hydrochloride

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R&D Status

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Indication	Country/Location	Organization	Date
Acute Bronchitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Cholecystitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Cystitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Dacryocystitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Hordeolum	JP	Shionogi & Co., Ltd.	22 Apr 1997
Intrauterine infection	JP	Shionogi & Co., Ltd.	22 Apr 1997
Jaw osteitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Laryngitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Mastitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Meibomianitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Otitis Externa	JP	Shionogi & Co., Ltd.	22 Apr 1997
Pericoronitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Periodontitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Pharyngitis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Pneumonia	JP	Shionogi & Co., Ltd.	22 Apr 1997
Pyelonephritis	JP	Shionogi & Co., Ltd.	22 Apr 1997
Pyoderma	JP	Shionogi & Co., Ltd.	22 Apr 1997
Skin Diseases, Infectious	JP	Shionogi & Co., Ltd.	22 Apr 1997
Suppuration	JP	Shionogi & Co., Ltd.	22 Apr 1997
Urethritis	JP	Shionogi & Co., Ltd.	22 Apr 1997

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