Trials / Completed

CompletedNCT07068841

Pharmacokinetic Effect of Y-3 on Repaglinide，Warfarin and Omeprazole in Healthy Participants

Study of the Pharmacokinetic Effect of Y-3 for Injection on Repaglinide Tablets, Warfarin Sodium Tablets, and Omeprazole Enteric-Coated Capsules in Healthy Participants

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 24 (actual)

Sponsor: Neurodawn Pharmaceutical Co., Ltd. · Industry
Sex: All
Age: 18 Years – 50 Years
Healthy volunteers: Accepted

Summary

The primary goal of this clinical trial is to evaluate the effect of Y-3 for injection on the pharmacokinetic profile of the sensitive finger substrates repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules for CYP2C8, CYP2C9, and CYP2C19 in Chinese healthy participants, to evaluate whether Y-3 for injection(40mg) will have clinical drug interactions with repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules, so as to provide a reference for the drafting of Y-3 drug instructions for injection and a basis for the safe and rational use of the drug after marketing. The secondary goal of this clinical trial is to observe the effect of Y-3 for injection on the safety of repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules. The main questions it aims to answer are: * What the pharmacokinetic profiles of repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules when using Y-3 (40 mg) in healthy participants. * If Y-3 for injection (40mg) will have clinical drug interactions with repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules * If Y-3 for injection (40mg) is safe in participants who using repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules. Researchers will see what the pharmacokinetic profiles and safety of repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules when using Y-3 (40 mg) in healthy participants. Participants will: * Take repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules without Y-3. * Take repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules during the use of Y-3. * Answer questions regarding your medical history. * Comply with the study procedures and requests. * Complete all tests and collections of PK Sampling. * Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay. * Must avoid excessive (\> 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study. * Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study. * Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study. * Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study. * Female participants must not become pregnant while in the study. * Must not receive any vaccinations during your time in the study. * Must not donate blood for purposes outside of study procedures during your time in the study. * Must not drink alcohol during your time in the study. * Must not smoke during your time in the study. * Inform your Study Doctor if you no longer wish to participate in the study.

Conditions

Interventions

Type	Name	Description
DRUG	sequentially single use of repaglinide, warfarin and omeprazole or combined with Y-3	Take repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules without Y-3. Take repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules sequentially during the use of Y-3.

Timeline

Start date: 2025-05-18
Primary completion: 2025-06-29
Completion: 2025-06-29
First posted: 2025-07-16
Last updated: 2025-12-11

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07068841. Inclusion in this directory is not an endorsement.