A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Health Volunteer

Treatments: Drug: HR091506 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07076459

HR091506-104

Details and patient eligibility

About

To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female between the ages of 18 and 50 years, inclusive.
2. At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
3. Prior to screening, during the trial, and for 90 days after the last administration, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
4. Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.

Exclusion criteria

1. Subjects with history of drug or food allergies.
2. Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems.
3. Use of any medication within 14 days prior to dosing.
4. Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 90 days before the trial, or plan to participate in other clinical trials during the study.
5. Subjects who have donated blood or experienced blood loss greater than 300 mL, or have received a blood transfusion or used blood products within 90 days prior to screening.
6. Subjects who take more than 5 cigarettes per day on average within 90 days prior to the study or do not agree to prohibit smoking during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Period 1: HR091506 tablet T1 Period 2: HR091506 tablet T2 Period 3: HR091506 tablet R

Treatment:

Drug: HR091506 tablet

Sequence 2

Experimental group

Description:

Period 1: HR091506 tablet T2 Period 2: HR091506 tablet R Period 3: HR091506 tablet T1

Treatment:

Drug: HR091506 tablet

Sequence 3

Experimental group

Description:

Period 1: HR091506 tablet R Period 2: HR091506 tablet T1 Period 3: HR091506 tablet T2

Treatment:

Drug: HR091506 tablet

Sequence 4

Experimental group

Description:

Period 1: HR091506 tablet T2 Period 2: HR091506 tablet T1 Period 3: HR091506 tablet R

Treatment:

Drug: HR091506 tablet

Sequence 5

Experimental group

Description:

Period 1: HR091506 tablet T1 Period 2: HR091506 tablet R Period 3: HR091506 tablet T2

Treatment:

Drug: HR091506 tablet

Sequence 6

Experimental group

Description:

Period 1: HR091506 tablet R Period 2: HR091506 tablet T2 Period 3: HR091506 tablet T1

Treatment:

Drug: HR091506 tablet