Publications by authors named "Haimiao Yang"
A single-dose, randomized, crossover bioequivalence study of levamlodipine besilate tablets in healthy subjects.
Naunyn Schmiedebergs Arch Pharmacol
October 2024
Levamlodipine, the levorotatory form of amlodipine racemate, has a blood pressure-lowering effect that is twice that of the racemate. The study aims to establish a foundation for the clinical application of the test drug by conducting a phase I clinical bioequivalence trial, comparing its bioequivalence and safety with the reference drug in healthy Chinese subjects. Recruiting 26 healthy subjects for separate bioequivalence trials in both fasting and fed conditions.
View Article and Find Full Text PDFPharmacokinetics and safety of a new generic lurasidone: a phase I bioequivalence study in healthy Chinese subjects.
Naunyn Schmiedebergs Arch Pharmacol
September 2024
Article Synopsis
- Latuda is an antipsychotic used for treating schizophrenia and bipolar depression, with bioequivalence trials conducted to compare it to its generic version, lurasidone.
- Two studies involving 28 subjects each tested both drugs under fasting and postprandial conditions, measuring key pharmacokinetic parameters like concentration (C) and area under the curve (AUC).
- Results showed that both Latuda and generic lurasidone met equivalence criteria, indicating they have similar effectiveness and safety profiles in healthy participants.
Article Synopsis
- - The study focused on comparing the pharmacokinetics (PK), bioequivalence, and safety of generic sunitinib and the original drug Sutent in healthy Chinese participants through a phase-I clinical trial.
- - Twenty-four subjects were randomly divided into two groups, each receiving either 12.5 mg of sunitinib or Sutent, with blood samples collected at 15 different times to assess the drugs' effectiveness and safety.
- - The results showed that the primary PK parameters for the two drugs were similar and within the bioequivalence range of 80%-125%, indicating that generic sunitinib is a safe and effective alternative to Sutent for treating certain conditions.
Background: Trastuzumab is a humanized anti-HER2 monoclonal antibody used in the treatment of breast cancer. This study compared the pharmacokinetics (PK), immunogenicity and safety of trastuzumab (Roche Pharma AG) and its biosimilar (Chia Tai Tianqing Pharmaceutical Group Co. Ltd) in healthy Chinese subjects.
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- Glucagon-like peptide-1 (GLP-1) is a hormone that helps lower blood sugar, and the study focused on comparing the effects of liraglutide, a GLP-1 receptor agonist, in healthy Chinese participants.
- A two-cycle cross-over study was conducted with 28 subjects receiving both test and reference drugs, measuring drug concentrations with advanced methods and assessing their bioequivalence and safety.
- Results showed that the two drugs had similar pharmacokinetic profiles, meeting bioequivalence standards and demonstrating good safety throughout the trial.
Article Synopsis
- Dasatinib is a tyrosine kinase inhibitor used for treating chronic myeloid leukemia and certain types of leukemia, with a focus on testing its bioequivalence with a generic version, YiNiShu®.
- The study involved fasting and fed conditions, where participants received either the branded drug or its generic, while various pharmacokinetic parameters were measured to assess bioequivalence.
- Results indicated that both drugs met bioequivalence standards, suggesting they have similar efficacy and safety profiles, which enhances treatment options for patients.
Objective: Imnovid® is an immunomodulatory drug with antineoplastic activity. The aim of this study was to evaluate the bioequivalence and safety of the generic drug pomalidomide (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and its originator product Imnovid® (Celgene Europe Ltd) in the fasting and fed states, respectively.
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- - The study was a phase I bioequivalence trial aimed at comparing the pharmacokinetics and safety of Cefaclor granules and suspensions in healthy Chinese subjects, both in fasting and postprandial states.
- - A total of 24 participants received a single dose of either formulation, with blood samples collected post-administration to evaluate drug absorption using LC-MS/MS for analysis.
- - Results showed that both formulations were bioequivalent, as their pharmacokinetic parameters fell within the 80-125% range, and the presence of food influenced the drugs' absorption characteristics.
Article Synopsis
- Bevacizumab, a targeted therapy for colorectal cancer, was compared to its biosimilar in a phase I clinical trial involving 98 healthy Chinese males.
- The trial measured drug concentrations and immunogenicity using advanced testing methods, confirming that both drugs had similar pharmacokinetic properties.
- Results showed that the biosimilar and original bevacizumab met bioequivalence standards and exhibited comparable safety profiles.
Article Synopsis
- This study investigated the bioequivalence and safety of afatinib, an irreversible ErbB family blocker, compared to Giotrif in healthy Chinese subjects.
- A total of 36 participants were divided into two groups to receive single doses of afatinib and Giotrif, with drug levels analyzed using LC-MS/MS over a 14-day washout period.
- The results showed that afatinib and Giotrif were bioequivalent, with geometric mean ratios within acceptable limits, and both drugs demonstrated good safety profiles throughout the trial.
Article Synopsis
- The text refers to a correction made to a scientific article published under the DOI 10.3389/fphar.2021.660541.
- This correction likely addresses errors or clarifications in the findings, methods, or details of the original research.
- The aim of such corrections is to ensure the accuracy and integrity of the published information in the field of pharmacology.
Article Synopsis
- Tofacitinib is an oral JAK inhibitor approved for treating inflammatory diseases, and a phase I trial compared its safety and effectiveness against Xeljanz® in healthy Chinese participants.
- The trial involved 32 subjects who were divided into two groups, alternating between 5 mg doses of tofacitinib and Xeljanz®, with blood sampled to analyze drug concentrations and safety.
- Results showed that the pharmacokinetic parameters of tofacitinib were similar to Xeljanz®, confirming its bioequivalence and supporting its clinical use.
Article Synopsis
- - The study focused on lenvatinib, a drug that inhibits specific receptor activities, and compared its bioequivalence and safety to Lenvima® through controlled trials involving healthy participants.
- - Participants were given either lenvatinib or Lenvima® in a crossover design with both fasting and post-meal conditions, and plasma drug concentrations were measured to assess equivalence.
- - Results indicated that both forms of the drug demonstrated similar bioavailability and safety profiles, with all values falling within the acceptable bioequivalence range, confirming that they can be used interchangeably in healthy Chinese subjects.
The dramatic increase of methicillin-resistant Staphylococcus aureus (MRSA) poses a great challenge to the treatment of Staphylococcus aureus (S. aureus) infections. Therefore, there is an urgent need to identify novel anti-infective agents to attack new targets to overcome antibiotic resistance.
View Article and Find Full Text PDFBiochanin A as an α-hemolysin inhibitor for combating methicillin-resistant Staphylococcus aureus infection.
World J Microbiol Biotechnol
November 2021
Methicillin-resistant Staphylococcus aureus (MRSA) is a multidrug-resistant pathogen that poses a significant risk to global health today. In S. aureus, α-hemolysin is an important virulence factor as it contributes to the capacity of the bacteria to infect the host.
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- This study evaluates the bioequivalence, immunogenicity, and safety of pertuzumab (a biosimilar) compared to Perjeta® (the original) in 87 healthy Chinese males.
- Results indicated that both drugs exhibited comparable pharmacokinetic profiles, with geometric mean ratios meeting bioequivalence standards.
- The levels of anti-drug and neutralizing antibodies were similar for both, suggesting they have comparable immunogenicity and safety.
Article Synopsis
- Pertuzumab, a monoclonal antibody for breast cancer, was tested for bioequivalence against the reference drug Perjeta® in a study involving 80 healthy Chinese male subjects.
- The study found that key pharmacokinetic parameters (C and AUC) showed similar values for both drugs, indicating that SHR-1309 is bioequivalent to Perjeta® as their ratios fell within the acceptable range of 80-125%.
- Immunogenicity and safety profiles were also comparable between the two drugs, with similar rates of antidrug antibodies and adverse reactions observed in both groups.
DNA self-assembled nanostructures have been considered as effective vehicles for biomolecule delivery because of their excellent biocompatibility, cellular permeability, noncytotoxicity, and small size. Here, we report an efficient antiviral strategy with self-assembled tetrahedral framework nucleic acids (tFNAs) delivering small interfering RNA (t-siRNA) to silence classical swine fever virus (CSFV) gene in porcine host cells. In this study, two previously reported siRNAs, C3 and C6, specifically targeting the CSFV genome were selected and modified on tFNAs, respectively, and termed t-C3 and t-C6.
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- The study investigated the bioequivalence, immunogenicity, and safety of adalimumab injecta (a biosimilar of Humira®) compared to Humira® in healthy Chinese males.
- A total of 164 participants received either adalimumab or Humira® through injection, and various parameters such as drug concentration, antibody levels, and physical health indicators were measured.
- Results showed that adalimumab and Humira® met bioequivalence standards, with similar levels of immunogenicity and safety, indicating they can be considered equivalent for clinical use.
Background: The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.
Aim: To evaluate the pharmacokinetic characteristics of esomeprazole magnesium (Eso) enteric- coated capsule in the healthy subjects in China and the bioequivalence of the two formulations.
Methods: This study was conducted in the Phase I Clinical Trial Unit of the Affiliated Hospital of Changchun University of Chinese Medicine.
The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial.
Evid Based Complement Alternat Med
September 2017
Background: Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS.
View Article and Find Full Text PDFAfter binding to the estrogen receptor, estrogen can alleviate the toxic effects of beta-amyloid protein, and thereby exert a therapeutic effect on Alzheimer's disease patients. Estrogen can increase the incidence of breast carcinoma and endometrial cancer in post-menopausal women, so it is not suitable for clinical treatment of Alzheimer's disease. There is recent evidence that the estrogen receptor can exert its neuroprotective effects without estrogen dependence.
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