Study of Smoking Effects on GS1-144 Tablet Absorption in Healthy Postmenopausal Chinese Women Aged 40 to 65

What this Trial Is About

This research aims to understand how smoking affects the way the body processes the drug GS1-144 in healthy Chinese postmenopausal women aged 40 to 65. The study focuses on drug interactions involving smoking, which is known to induce certain liver enzymes, potentially changing the drugs behavior in the body. Participants are healthy females who meet specific criteria related to postmenopausal status and smoking habits. Participants will receive a single oral dose of GS1-144 tablets at 30 mg. The study uses an open-label, parallel design to compare the drugs pharmacokinetics between smokers and non-smokers. Smokers must continue their usual smoking habits in designated areas during the study. The trial assesses how smoking influences key pharmacokinetic parameters of GS1-144 and its primary metabolite over a period of up to 72 hours after dosing. During the study, participants will undergo various assessments including blood sampling for measuring drug levels, vital signs monitoring, and laboratory tests. The main outcomes measured are drug concentration peaks and exposure over time, metabolism rates, and elimination half-life. Safety will be monitored throughout the 72-hour post-dose period to capture any adverse events. Participants are expected to comply with study requirements and provide informed consent prior to enrollment.

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