Article
Chemistry, Medicinal
Chunqi Huang, Zhou Yin, Yeqing Yang, Nan Mo, Hui Yang, Ying Wang
Summary: The purpose of this study was to explore the pharmacokinetics, bioequivalence, food effect, and safety of oral ibuprofen sustained-release capsules from two different sponsors. The findings showed that ibuprofen had a favorable safety profile and achieved bioequivalence under both fasting and fed conditions.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Pharmacology & Pharmacy
Ping Du, Zhixia Zhao, Weiyue Yu, Rui Zhao, Hongchuan Liu, Pengfei Li, Lihong Liu
Summary: The bioequivalence of test and reference formulation of gefitinib was evaluated in healthy Chinese volunteers through a randomized, open-label, two-period, two-sequence crossover study. The results showed that the 90% confidence interval of the geometric mean ratios of the two formulations were within the range of 0.80-1.25 under fasting and fed conditions. No serious or unexpected adverse events occurred during the study.
JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY
(2023)
Article
Veterinary Sciences
Yan-Yan Gao, Ka-Na Sang, Peng-Peng Li, Jie Hao, Cong Zhang, Huan-Juan Li, De-Gang Zhou
Summary: The pharmacokinetic profiles and bioequivalence of two cefpodoxime proxetil tablets were investigated in Beagle dogs. The results showed that there were no significant differences in the pharmacokinetic parameters between the test formulation and the reference one, indicating bioequivalence.
FRONTIERS IN VETERINARY SCIENCE
(2022)
Article
Chemistry, Medicinal
Qiuying Li, Lihui Jia, Wenli Hu, Shu Dong, Chaohong Cai
Summary: The study evaluated the bioequivalence and safety of two formulations of 25 mg tenofovir alafenamide tablets in Chinese healthy male and female subjects under fed and fasting conditions. The results showed that both formulations met the bioequivalence acceptance criteria and were well tolerated by the subjects, demonstrating bioequivalence in pharmacokinetic parameters under different feeding conditions.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Chemistry, Medicinal
Qian Zhang, Zhiqiang Wang, Jingying Wu, Zhen Zhou, Renpeng Zhou, Wei Hu
Summary: The study demonstrated that two formulations of 40 mg Regorafenib were bioequivalent under fasting and fed conditions in healthy Chinese volunteers, with similar and generally good safety profiles.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Pharmacology & Pharmacy
Yaping Deng, Guohua Wang, Guojun Jiang, Dandan Song, Xian Xu, Dandan Zhao, Guojun Tan, Zijun Tan, Jian Chen
Summary: The supply of branded 6-mercaptopurine (6-MP) is limited in China, requiring the production and evaluation of generic alternatives. This study assessed the in vivo bioequivalence of a new generic 6-MP tablet by comparing its pharmacokinetic parameters with a branded reference product in healthy Chinese adults. The results indicated that the generic alternative met the regulatory criteria for bioequivalence and exhibited a similar safety profile as the reference product.
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
(2023)
Article
Pharmacology & Pharmacy
Xu Zuo, Xin Zhao, Tiandong Zhang
Summary: This study evaluated the bioequivalence of two methotrexate tablets under fasting and fed conditions and found that they were bioequivalent in both conditions. No serious adverse reactions or events were observed.
NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY
(2023)
Article
Medicine, Research & Experimental
Qiuying Li, Zhen Hao, Yan Yu, Yunbiao Tang
Summary: The study showed that test and reference formulations of perindopril tert-butylamine tablets were bioequivalent in healthy Chinese subjects under fasting and fed conditions, with similar pharmacokinetic profiles and tolerability.
BIOMEDICINE & PHARMACOTHERAPY
(2021)
Article
Pharmacology & Pharmacy
Marcelo Gomes Davanco, Jessica Meulman, Thalita Martins da Silva, Fernando Costa, Karini Bruno Bellorio, Iram Moreira Mundim, Ana Carolina Costa Sampaio, Leonardo de Souza Teixeira, Celso Francisco Pimentel Vespasiano
Summary: This study aimed to evaluate the bioequivalence between two methylphenidate extended-release tablets and found that the test formulation was considered bioequivalent to the reference formulation in both fasting and fed conditions. Both formulations were safe and well tolerated.
Article
Chemistry, Medicinal
Weihong Li, Yanrong Wang, Yingzi Pei, Yue Xia
Summary: The study aimed to compare the pharmacokinetic properties and bioequivalence of montelukast sodium chewable tablets from two manufacturers in Chinese volunteers. The results showed that the two formulations were bioequivalent and had similar safety profiles in healthy Chinese subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Article
Pharmacology & Pharmacy
Taweegrit Siripongboonsitti, Teerapat Ungtrakul, Natcha Watanapokasin, Pornuma Timsri, Kawinthida Wongpakdee, Parin Wattanasin, Chiravi Pavitrapok, Ariya Khunvichai, Promporn Jamnongtanachot, Wunlapa Mueannoom, Tanya Kitpoka, Weena Arjharn, Nithi Mahanonda
Summary: This study compared the pharmacokinetics and safety of favipiravir oral solution and tablet formulations. The results showed bioequivalence between the two formulations, with the oral solution offering the advantage of easier swallowing for patients.
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
(2023)
Article
Pharmacology & Pharmacy
Onursal Saglam, Berrak Guney, Nihal Saraner, Gamze Sevici, Emel Dogan-Kurtoglu, Merve G. Ulusoy, Gokce Demiray, Muradiye Nacak, Aydin Erenmemisoglu, Mahmut Ozbek, Peri Aytac
Summary: This study aimed to demonstrate the bioequivalence of a new favipiravir tablet formulation compared to the reference tablet formulation in healthy male subjects under fasting conditions. The results showed that the test and reference favipiravir products met the required bioequivalence criteria, and both products were well tolerated and safe.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
(2021)
Article
Multidisciplinary Sciences
Shaheen Perveen, Shahnaz Gauhar, Rabia Ismail Yousuf, Huma Ali, Farya Zafar, Anab Fatima Sheikh
Summary: This study evaluated the effect of ranitidine on the pharmacokinetics of amoxicillin. The results showed that ranitidine significantly reduced the peak plasma concentration of amoxicillin. Therefore, it is recommended to administer both drugs with a time interval to enhance the therapeutic effect of amoxicillin.
Article
Pharmacology & Pharmacy
Chengmei Dong, Xiaonan Zhang, Yalan Zhang, Wenjuan Ouyang, Daizhuang Peng, Xiaomin Li, Dai Li, Qun Qin
Summary: This study investigated the effects of food on the pharmacokinetics, bioequivalence, and safety of ticagrelor tablets in healthy Chinese volunteers. The results showed that food consumption increased ticagrelor concentrations, decreased C-max, and prolonged the half-life of AR-C124910XX.
BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY
(2023)
Article
Pharmacology & Pharmacy
Lianlian Fan, Peiwen Zhang, Chunyan Gan, Qian Huang, Zhen Shen, Xue Xiao, Ying Yang, Daicong Qiu, Gang Mai, Jianzhong Shentu
Summary: This study aimed to evaluate and compare the pharmacokinetic profiles and bioequivalence of a Chinese test formulation and a reference formulation of methylprednisolone in healthy Chinese subjects. The results showed that there were no significant differences in the primary pharmacokinetic parameters between the test and reference formulation, indicating that the test formulation is bioequivalent to the reference formulation in healthy Chinese subjects. Both formulations were well tolerated by the study participants.
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
(2023)