A Drug-Drug Interaction Study to Evaluate the Effect of Smoking (CYP1A2 Inducer) on the Pharmacokinetics Following a Single Oral Dose of GS1-144 Tablets in Chinese Healthy Postmenopausal Female Trial Participants
Consecutive spontaneous amenorrhea ≥ 12 months.
Consecutive spontaneous amenorrhea ≥ 6 months but < 12 months, with serum follicle-stimulating hormone (FSH) levels > 40 IU/L.
≥ 6 weeks after bilateral oophorectomy.
History of hysterectomy with preservation of one or both ovaries and FSH levels > 40 IU/L.
Known history of hypersensitivity to the investigational drug, any of its excipients, or related formulations; or a history of allergic disorders (including but not limited to asthma, urticaria); or being allergy-prone (e.g., known allergy to two or more substances).
History or current diagnosis of diseases of the circulatory, digestive, urinary, respiratory, endocrine and metabolic, hematological and lymphatic, immune, psychiatric and neurological, or dermatological systems, and deemed unsuitable for participation by the investigator.
History of severe infection, serious trauma, or major surgery within 6 months prior to screening, or planning to undergo surgery during the trial.
Blood donation or blood loss ≥ 400 mL, or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood within 1 month after the end of the trial.
Single group
GS1-144 tablets
DrugAll trial participants will receive the investigational drug (GS1-144 tablets) at a dose of 30 mg.
Primary PK parameters for GS1-144: Cmax.
Primary PK parameters for GS1-144: AUC0-t.
Primary PK parameters for GS1-144: AUC0-∞.
Secondary PK parameters of GS1-144: Tmax.
PK parameters of the primary metabolite M1: Cmax.
PK parameters of the primary metabolite M1: AUC0-t.
PK parameters of the primary metabolite M1: AUC0-∞.
:PK parameters of the primary metabolite M1: Tmax.
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