Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects

NCT ID: NCT06354556

Last Updated: 2024-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2024-05-20

Brief Summary

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The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.

Detailed Description

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Conditions

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Obstructive Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single center, open, single arm, fixed sequence
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

HRS-1893 tablet

Intervention Type DRUG

HRS-1893 tablet single dose

Verapamil tablet

Intervention Type DRUG

Verapamil tablet 80 mg tid

Interventions

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HRS-1893 tablet

HRS-1893 tablet single dose

Intervention Type DRUG

Verapamil tablet

Verapamil tablet 80 mg tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).
2. Male or female aged 18-55(adult healthy volunteers).
3. Body mass index (BMI) between 19 and 28 kg/m2.
4. Normal Electrocardiogram (ECG).

Exclusion Criteria

1. History of persistent tachyarrhythmia and syncope.
2. A history of stomach or bowel surgery or excision.
3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
4. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HRS-1893-102

Identifier Type: -

Identifier Source: org_study_id

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