Healthy Postmenopausal WomenPhase 1NCT06983925
A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women
A Phase 1 study testing GS1-144 Tablet with new preparation (T) and GS1-144 Tablet with present preparation (R) in people with Healthy Postmenopausal Women, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Postmenopausal Women
- What is being tested?
- GS1-144 Tablet with new preparation (T) and GS1-144 Tablet with present preparation (R)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 14 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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.
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- (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.
- (Screening period/admission consultation) With a history of drug abuse at present or within 1 year.
- (Screening period/admission consultation) Smoked more than 5 cigarettes per day in the 3 months before screening, or could not stop using any tobacco products during the study period.
- (During admission) Who had a positive breath test for alcohol or had been an alcoholic for 3 months prior to screening, i.e. had consumed more than 14 units of alcohol per week (one standard unit is 17.5 mL or 14 g of pure alcohol, the alcohol content of different types of alcohol is indicated by volume, and one standard unit is approximately 35 mL of 50° liquor or 350 mL of 5° beer); Or unwilling to stop drinking alcohol or consuming any alcohol-based products during the trial.
- (During the admission period) With positive results of multiple drug tests in urine.
- (Screening period/admission inquiry) Who had consumed any food or beverage (e.g. those containing grapefruit, star fruit or their products) that might affect the metabolism of the study drug within 48 hours before admission to the phase I ward in each cycle.
- (Screening period/admission consultation) Excessive consumption (> 8 cups/day, 1 cup =250 mL) of tea, coffee or caffeinated beverages per day in the 3 months before screening; Or intake of any food or beverage (such as coffee, tea, chocolate, cola, etc.) containing or metabolized caffeine or xanthine within 24 hours before admission to phase I ward.
- Clinically significant abnormal pregnancy test results or (screening/admission inquiry) lactating women.
- Those who have difficulty in venous blood collection and/or cannot tolerate venipuncture/indwelling needle or feel dizzy with needles or blood.
- Other conditions that were considered by the investigator to be ineligible for inclusion in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Healthy Postmenopausal Women
- Being tested
- GS1-144 Tablet with new preparation (T), GS1-144 Tablet with present preparation (R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS1-144 Tablet with new preparation (T)Drug
GS1-144 Tablet with new preparation (T)
GS1-144 Tablet with present preparation (R)Drug
A single oral dose of GS1-144 Tablet with present preparation
| Study group | Role | What they receive |
|---|---|---|
| T-R | Experimental | Administration order: GS1-144 Tablet with new preparation (T), GS1-144 Tablet with present preparation (R) Receives: Drug: GS1-144 Tablet with new preparation (T); Drug: GS1-144 Tablet with present preparation (R) |
| R-T | Experimental | Administration order: GS1-144 Tablet with present preparation (R), GS1-144 Tablet with new preparation (T), Receives: Drug: GS1-144 Tablet with new preparation (T); Drug: GS1-144 Tablet with present preparation (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (Area under the blood concentration-time curve from 0 to the last quantifiable time point after administration (AUC0-t)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (Area under the blood concentration-time curve from 0 to infinity (AUC0-∞)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (time to peak (Tmax)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (rate constant of drug elimination (λz)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (elimination half-life (t1/2)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (apparent clearance rate (CL/F)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (apparent volume of distribution (Vz/F)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Pharmacokinetics (relative bioavailability (F%)) of GS1-144 with present and new preparation
Measured: 0 hours -72 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start30 Apr 2025
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Postmenopausal WomenStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983925
- Sponsor's protocol ID
- GenSci074-103
- Status last verified
- Apr 2025
- First submitted
- 6 May 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06983925
- Acronym / sponsor ID
- GenSci074-103
- Conditions
- Healthy Postmenopausal Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-R | Experimental | Drug: GS1-144 Tablet with new preparation (T), Drug: GS1-144 Tablet with present preparation (R)Administration order: GS1-144 Tablet with new preparation (T), GS1-144 Tablet with present preparation (R) |
| R-T | Experimental | Drug: GS1-144 Tablet with new preparation (T), Drug: GS1-144 Tablet with present preparation (R)Administration order: GS1-144 Tablet with present preparation (R), GS1-144 Tablet with new preparation (T), |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS1-144 Tablet with new preparation (T)GS1-144 Tablet with new preparation (T) | Drug | R-T, T-R |
| GS1-144 Tablet with present preparation (R)A single oral dose of GS1-144 Tablet with present preparation | Drug | R-T, T-R |
Primary outcome
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (Area under the blood concentration-time curve from 0 to the last quantifiable time point after administration (AUC0-t)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (Area under the blood concentration-time curve from 0 to infinity (AUC0-∞)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (time to peak (Tmax)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (rate constant of drug elimination (λz)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (elimination half-life (t1/2)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (apparent clearance rate (CL/F)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (apparent volume of distribution (Vz/F)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Pharmacokinetics (relative bioavailability (F%)) of GS1-144 with present and new preparation
Time frame: 0 hours -72 hours post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS1-144 Tablet with new preparation (T) and GS1-144 Tablet with present preparation (R) in people with Healthy Postmenopausal Women, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of GS1-144 with present and new preparation (time frame: 0 hours -72 hours post-administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.