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To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects

Clinical Trial Summary

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Clinical Trial Description

1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation. To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement. 2. All subjects who received more than one dose of clinical trial drugs are evaluated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05433844
Study type Interventional
Source JW Pharmaceutical
Contact
Status Completed
Phase Phase 1
Start date June 2, 2022
Completion date September 14, 2022
View Details
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