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A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women

A Randomized, Open-label, Single-dose, Two-crossover Bioavailability Study of Single Oral Administration of GS1-144 Tablets Under Fasting Condition in Healthy Postmenopausal Female Subjects in China

NCT06983925•Changchun GeneScience Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the pharmacokinetic (PK) characteristics of GS1-144 tablets and the relative bioavailability of the two preparations in healthy postmenopausal female subjects in China.

Detailed Description

To evaluate the pharmacokinetic (PK) characteristics of GS1-144 tablets and the relative bioavailability of the two preparations in healthy postmenopausal female subjects in China.

Eligibility

Age

40 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•At the time of signing the Informed consent Form (ICF) : age between 40 and 65 years (inclusive of boundary values).
•Postmenopausal female subjects: Natural menopause (defined as continuous spontaneous amenorrhea for ≥ 12 months, except for lactation or surgical menopause, or continuous spontaneous amenorrhea for ≥ 6 months, serum follicle stimulating hormone (FSH) \> 40 IU/L, and serum estradiol (E2) concentration less than the upper limit of the normal range in postmenopausal women; Or ≥ 6 weeks after bilateral oophorectomy (with/without hysterectomy).
•Weight ≥ 45 kg with body mass index (BMI) in the range of 18-28 kg/m2 (inclusive of boundary values).
•Be able to communicate well with researchers, understand and comply with the requirements of this study, voluntarily participate in the trial, understand and sign ICF.

Exclusion Criteria

•(Screening/admission) Known allergic history to the study drug and any of its components or related preparations, or history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergic history to two or more substances).
•(Screening period/admission interrogation) Patients with any previous or current cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urinary, pulmonary, neurological, cutaneous, psychiatric, renal and/or other major diseases considered by the investigators as clinically significant.
•(Screening period/admission inquiry)Patients with severe infection, severe trauma or major surgical operation within 6 months before the first administration.
•(Screening period/admission inquiry) Received blood transfusion within 3 months before the first dose, or had blood donation, or had blood loss ≥400 mL, or planned to donate blood within 1 month after the end of the study.
•Abnormal detection of infectious diseases with clinical significance, such as positive human immunodeficiency virus antigen (HIV Ag) or antibody (HIV Ab), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or treponema pallidum antibody or specific antibody.
•(Screening period/admission inquiry) Were enrolled in another clinical trial within 3 months before the first dose (except those who did not receive any intervention) or were enrolled in another clinical trial.
•(Screening period/admission inquiry) Use of any prescribed medication \[including but not limited to any medication that changes liver enzyme activity (e.g., glucocorticoids, sex hormones, anticonvulsants, cyclosporine, etc.)\] within 4 weeks before the first dose of medication; Or use of any non-prescription drugs (including but not limited to Chinese herbal medicine, compound preparations of Chinese herbal medicine, health supplements, etc.) and vitamin supplements within 2 weeks before administration; Those who had taken an inducer of cytochrome P450 1A2 (CYP1A2) within 3 months before taking the study drug or had taken a CYP1A2 inhibitor within the previous 2 weeks or 5 half-lives, the longer.
•Clinically significant abnormal results of physical examination, chest X-ray, abdominal ultrasound or reproductive organ ultrasound at screening; Patients with clinically significant abnormal thyroid function, parathyroid function or neck ultrasound examination results; Abnormal laboratory tests with clinical significance.
•Clinically significant abnormal vital signs, in which abnormal blood pressure was defined as systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, diastolic blood pressure ≥ 90 mmHg or \< 60 mmHg.
•Prolonged QT interval corrected with Fridericia's formula (QTcF \> 460 ms in women, Fridericia's formula: QTcF = QT/RR0.33) on 12-lead electrocardiogram at screening, or other clinically significant abnormalities.
+9 more criteria

Locations (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China

Key Dates

Start Date

April 30, 2025

Primary Completion Date

July 14, 2025

Completion Date

July 14, 2025

Last Updated

August 8, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Postmenopausal Women

Interventions

GS1-144 Tablet with new preparation (T)

DRUG

GS1-144 Tablet with present preparation (R)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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