Publications by authors named "Chunpu Lei"
Article Synopsis
- The study aimed to assess the pharmacokinetic bioequivalence and safety of a generic version of pegylated liposomal doxorubicin compared to the reference product, Caelyx, in breast cancer patients.
- A single-dose, randomized crossover design was used, with 48 patients receiving both the test and reference formulations at specified intervals, tracking various blood measurements over 14 days.
- Results indicated that the generic formulation was bioequivalent to Caelyx, as demonstrated by overlapping confidence intervals, and no significant safety differences were noted between the two treatments, despite a high occurrence of laboratory abnormalities.
Article Synopsis
- - The study compared the adalimumab biosimilar SCT630 with the reference drug adalimumab (Humira®) in terms of pharmacokinetics, safety, and immunogenicity among 146 healthy participants receiving a single subcutaneous dose.
- - Key pharmacokinetic measures showed that SCT630 was bioequivalent to adalimumab, with both AUC and maximum serum concentration ratios falling within the acceptable range for equivalence.
- - Both SCT630 and adalimumab had similar rates of treatment-emergent adverse events and anti-drug antibody responses, suggesting SCT630 is well tolerated and clinically comparable to adalimumab, warranting further confirmatory studies.
SCTA01 is a novel monoclonal antibody with promising prophylactic and therapeutic potential for COVID-19. This study aimed to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of SCTA01 in healthy adults. This was a randomized, double-blind, placebo-controlled, dose escalation phase I clinical trial.
View Article and Find Full Text PDFThe study evaluated the safety, tolerability, pharmacokinetics (PK) and anti-drug antibody (ADA) of the recombinant human thymosin β4 (NL005) for single and multiple intravenous injections in healthy subjects. Seven cohorts, with 54 healthy subjects, were given a single intravenous dose of NL005 or placebo and were observed for 28 days. The cohorts received ascending doses of either 0.
View Article and Find Full Text PDFThis study compared the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar TAB008 monoclonal antibody to bevacizumab (Avastin) in normal healthy Chinese male volunteers. In this randomized, double-blind, parallel controlled study, a total of 100 healthy Chinese male subjects were randomized (1:1) to receive a single 1 mg/kg intravenous dose of TAB008 or Avastin over a 90-min infusion. The subjects were followed for 99 days after drug administration.
View Article and Find Full Text PDFBioequivalence study of single-dose lenalidomide capsule vs. Revlimid capsule in healthy Chinese males.
Cancer Chemother Pharmacol
July 2018
Objective: Lenalidomide is a 4-amino-glutaryl derivative of thalidomide and belongs to a new generation of immunomodulatory agents for the treatment of patients with myelodysplastic syndrome and multiple myeloma. The aim of this study is to evaluate the bioequivalence and safety of a capsule containing 25 mg of a test formulation of lenalidomide and a 25 mg Revlimid capsule in healthy, Chinese adult males for good quality anti-cancer medicine with lower costs.
Methods: This was a single-center, randomized, open-label, single-dose, two-period, crossover pharmacokinetic study.