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Brief Title: PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
Official Title: PPK Study Based on Quantitative Pharmacology in Patients With Pamipril
Study ID: NCT05848648
Brief Summary: This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.
Detailed Description: In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation. Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ,blood concentration ,combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Xin Huang, Jinan, Shandong, China
Name: Huang Xin
Affiliation: Qianfoshan Hospital
Role: STUDY_DIRECTOR