[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of cefaclor dry suspension in healthy subjects under fasting/fed conditions

主要目的：健康受试者空腹/餐后状态下，口服单剂量头孢克洛干混悬剂（受试制剂T，广州白云山医药集团股份有限公司白云山制药总厂生产，规格：0.125g/包）与头孢克洛干混悬剂（参比制剂R，苏州西克罗制药有限公司生产，商品名：希刻劳®/CECLOR®，规格：0.125g/袋）后，考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。次要目的：观察受试制剂头孢克洛干混悬剂和参比制剂头孢克洛干混悬剂（希刻劳®/CECLOR®）在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions after oral administration of a single dose of cefaclor dry suspension (test preparation T, produced by Baiyunshan Pharmaceutical Factory of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., specification: 0.125g/bag) and cefaclor dry suspension (reference preparation R, produced by Suzhou Xikro Pharmaceutical Co., Ltd., trade name: Xikro®/CECLOR®, specification: 0.125g/bag) to healthy subjects, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation cefaclor dry suspension and the reference preparation cefaclor dry suspension (Xikro®/CECLOR®) in healthy subjects.

Start Date16 Feb 2023

Sponsor / Collaborator

Guangzhou Baiyunshan General Pharmaceutical Factory

CTR20223059

/ CompletedNot Applicable

头孢克洛胶囊在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验

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

头孢克洛胶囊在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验

[Translation]

A single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting/fed bioequivalence study of cefaclor capsules in healthy subjects

Start Date06 Jan 2023

Sponsor / Collaborator

Anhui Renji Pharmaceutical Co. Ltd.

CTR20222966

/ CompletedNot Applicable

海口市制药厂有限公司生产的头孢克洛干混悬剂（0.125 g）与苏州西克罗制药有限公司持证的头孢克洛干混悬剂（商品名：希刻劳®，0.125 g）在健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究

[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of cefaclor dry suspension (0.125 g) produced by Haikou Pharmaceutical Factory Co., Ltd. and cefaclor dry suspension (trade name: Xikeluo®, 0.125 g) certified by Suzhou Xikeluo Pharmaceutical Co., Ltd. in healthy subjects under fasting and fed conditions

主要研究目的：以苏州西克罗制药有限公司持证的头孢克洛干混悬剂为参比制剂，以海口市制药厂有限公司生产的头孢克洛干混悬剂为受试制剂，通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the cefaclor dry suspension certified by Suzhou Xikro Pharmaceutical Co., Ltd. as the reference preparation and the cefaclor dry suspension produced by Haikou Pharmaceutical Factory Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting and fed state through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date14 Dec 2022

Sponsor / Collaborator

Haikou Pharmaceutical Co. Ltd.

100 Clinical Results associated with Urethral Infection

100 Translational Medicine associated with Urethral Infection

0 Patents (Medical) associated with Urethral Infection

273

Literatures (Medical) associated with Urethral Infection

01 Nov 2024·Sexually Transmitted Infections

Prevalence of Mycoplasma genitalium and macrolide resistance in rectal and urine samples among men who have sex with men in Sweden

Article

Author: Kristiansen, Sinja ; Forslund, Ola ; Kertes, Rebecca ; Bjartling, Carina ; Johnsson, Annika

Objectives While Mycoplasma genitalium is reported as a common rectal infection among men who have sex with men (MSM), published data refer predominantly to urethral infections. Currently, most guidelines recommend M. genitalium testing from urine in men with symptomatic, non-gonococcal urethritis. Macrolide resistance-associated mutations (MRMs) among M. genitalium have increased during the last decade especially among MSM. We aim to demonstrate the prevalence and anatomical distribution of M. genitalium infection and MRM in urine and rectal specimens among MSM in Sweden. Methods In this cross-sectional study in 2019, paired urine and rectal samples from symptomatic and asymptomatic MSM attending a sexually transmitted infection clinic in the south of Sweden were screened for M. genitalium , presence of MRM, Neisseria gonorrhoeae , Chlamydia trachomatis , HIV and syphilis. Results The overall prevalence of M. genitalium was 10.5% (64 of 609), rectal samples 7.6% (46 of 609) and urine samples 3.9% (24 of 609) (p=0.007). Among M. genitalium -positive cases, single rectal and single urethral infection was detected in 62.5% (40 of 64) and 28.1% (18 of 64), respectively (p<0.0001). Infection at both sites was seen in 9.4% (6 of 64). The prevalence of MRM was 67.9% (19 of 28). M. genitalium was significantly associated with HIV (OR 2.60, 95% CI 1.14 to 5.88, p=0.02). Among the MSM, 7.4% (45 of 609) were infected with N. gonorrhoeae, 6.7% (41 of 609) with C. trachomatis , 7.1% (43 of 609) with HIV and 0.7% (4 of 609) with syphilis. Conclusions In this study, among MSM, most infections with M. genitalium were detected as rectal mono infections. The prevalence of M. genitalium among MSM was almost twofold higher in rectal samples (7.6%) compared with urine samples (3.9%). The prevalence of macrolide resistance was high with no difference between urine and rectal samples.

01 Nov 2024·Sexually Transmitted Diseases

Mycoplasma genitalium Infections Among Participants in an HIV Pre-exposure Prophylaxis Program in Hanoi, Vietnam

Article

Author: Truong, Phuong T. ; Nguyen, Khanh D. ; Le, Ngan T. ; Klausner, Jeffrey D. ; Le, Giang M. ; Pham, Loc Q. ; Bui, Hao TM. ; Adamson, Paul C.

BackgroundMycoplasma genitalium causes a sexually transmitted infection and is also emerging as an important antimicrobial resistant pathogen. Data on M. genitalium infections among men who have sex with men (MSM) in low-resource settings are sparse.MethodsFrom January to December 2022, participants in an HIV pre-exposure prophylaxis (PrEP) program in Hanoi, Vietnam were enrolled into the study. Demographic, behavioral, and clinical characteristics were collected. Self-collected urine, rectal, and pharyngeal specimens were tested for M. genitalium using the Alinity m STI Assay (Abbott Molecular, USA). Univariate and multivariate logistic regression were performed to assess for factors associated with infections.ResultsAmong 477 participants, the median age was 25.3 years (21.7–29.6) and 92.2% (n = 440) identified as MSM; 48.6% had ≥2 sex partners and 38.1% reported condomless anal sex in the prior month. The overall prevalence of M. genitalium infection was 10.9% (52/477); 7.3% (34/464) rectal, 3.2% (15/476) urethral, and 1.9% (9/476) pharyngeal. Infections were asymptomatic in 71.2% (37/52). Among those with M. genitalium, 30.7% (16/52) were co-infected with either Neisseria gonorrhoeae or Chlamydia trachomatis. Among those reporting rectal (n = 51) or urethral (n = 35) symptoms, but without C. trachomatis or N. gonorrhoeae co-infections, five (9.8%) had rectal infections and one (2.9%) had urethral infection. Participants with M. genitalium were more likely to be asymptomatic than participants without M. genitalium (adjusted odds ratio, 1.93; 95% confidence interval, 1.01–3.71).ConclusionsMycoplasma genitalium infections were common among primarily MSM engaged in an HIV PrEP program in Vietnam. The prevalence was highest in rectal specimens and nearly three quarters of M. genitalium infections were asymptomatic. Testing for M. genitalium infections among those with symptoms is important to enable pathogen-directed therapy. Additional research on antimicrobial resistance and treatment strategies for M. genitalium in low-resource settings is needed.

01 Nov 2023·Emerging Infectious Diseases

Detection of Novel US Neisseria meningitidis Urethritis Clade Subtypes in Japan

Review

Author: Akeda, Yukihiro ; Kojima, Munekado ; Takahashi, Hideyuki ; Morita, Masatomo ; Yasuda, Mitsuru ; Kobori, Yoshitomo ; Ohnishi, Makoto ; Shimuta, Ken ; Ohama, Yuki

Neisseria meningitidis causes invasive meningococcal diseases and has also been identified as a causative agent of sexually transmitted infections, including urethritis. Unencapsulated sequence type 11 meningococci containing the gonococcal aniA-norB locus and belonging to the United States N. meningitidis urethritis clade (US_NmUC) are causative agents of urethral infections in the United States, predominantly among men who have sex with men. We identified 2 subtypes of unencapsulated sequence type 11 meningococci in Japan that were phylogenetically close to US_NmUC, designated as the Japan N. meningitidis urethritis clade (J_NmUC). The subtypes were characterized by PCR, serologic testing, and whole-genome sequencing. Our study suggests that an ancestor of US_NmUC and J_NmUS urethritis-associated meningococci is disseminated worldwide. Global monitoring of urethritis-associated N. meningitidis isolates should be performed to further characterize microbiologic and epidemiologic characteristics of urethritis clade meningococci.

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