A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations (NCT07345689) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations
China60 participantsStarted 2026-01-30
Plain-language summary
The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;
✓. Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;
✓. Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);
✓. Body mass index (BMI) between 18 and 32 kg/m² (inclusive);
✓. Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;
✓. Subjects in the hepatic impairment group must also meet all of the following additional criteria:
✓. Subjects in the renal impairment group must also meet all of the following additional criteria:
Exclusion criteria
✕. Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;
. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;
✕. History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;
✕. History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;
✕. Receipt of any vaccine within 14 days prior to screening, or intention to receive any vaccination during the course of the study;
✕. Donation or loss of blood ≥ 400 mL within 3 months prior to screening, or intention to donate blood during the study;
✕. Use of moderate or strong CYP3A4 inhibitors/inducers within 2 weeks prior to screening, or planned concomitant use during the study; or use of CYP3A4-sensitive substrates within 2 weeks prior to screening or planned use during the study;