A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanzhu Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
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;
QTcF (male) > 470 ms, QTcF (female) > 480 ms;
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Anaprazole Sodium enteric-coated tablet
Drug20 mg single dose
Treatment groups
60 Participants
are divided into 5 treatment groupsGroup A: Healthy subjectsExperimental treatment 1 intervention
Group B: Moderate hepatically impaired subjectsExperimental treatment 1 intervention
Group C: Moderate renal impaired subjectsExperimental treatment 1 intervention
Group D: Severe renal impaired subjectsExperimental treatment 1 intervention
Group E: Elderly subjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cmax
Cmax of anaprazole sodium in healthy subjects and special participant populations.
Time frame
Up to 48 hours from anaprazole sodium administration2
Tmax
Tmax of anaprazole sodium in healthy subjects and special participant populations.
Time frame
Up to 48 hours from anaprazole sodium administration3
AUC0-t
AUC0-t of anaprazole sodium in healthy subjects and special participant populations.
Time frame
Up to 48 hours from anaprazole sodium administration4
AUC0-∞
AUC0-∞of anaprazole sodium in healthy subjects and special participant populations.
Time frame
Up to 48 hours from anaprazole sodium administrationSecondary outcomes
1
Number of Subjects With Adverse Events (AEs)
Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication to the end of the study.
Time frame
Up to 7 days from the start of administrationSponsors and contacts
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Source ClinicalTrials.gov
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