Publications by authors named "Xinyao Qu"
Pharmacokinetics 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.
Background: To provide a reference for clinical selection of collagen membranes by analyzing the properties of three kinds of collagen membranes widely used in clinics: Bio-Gide membrane from porcine dermis (PD), Heal-All membrane from bovine dermis (BD), and Lyoplant membrane from bovine pericardium (BP).
Methods: The barrier function of three kinds of collagen membranes were evaluated by testing the surface morphology, mechanical properties, hydrophilicity, and degradation rate of collagen membranes in collagenase and artificial saliva. In addition, the bioactivity of each collagen membrane as well as the proliferation and osteogenesis of MC3T3-E1 cells were evaluated.
Article Synopsis
- 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
- - 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
- 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.
Article Synopsis
- 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.
Article Synopsis
- 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.
The Toxic Effects of Ethylene Glycol Tetraacetate Acid, Ferrum Lek and Methanol on the Glutathione System: correction Options.
Expert Rev Clin Pharmacol
January 2021
: The purpose of this study was to measure the level of lipid peroxidation and investigate the response of the glutathione system to toxic doses of ethylene glycol tetraacetate acid (EGTA), Ferrum Lek, methanol, and Depakine (valproate sodium). : This study focused on analyzing the toxic effects of EGTA, Ferrum Lek and methanol on lipid peroxidation processes and glutathione levels in animals. The study involved 375 outbred adult mice, of both sexes, weighing 28-31 g, and 100 outbred rats, weighing 180-200 g.
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