To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .

ConditionPostmenopause
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GS1-144 tablets

Treatment groups

24 Participants
are divided into 1 treatment group