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
Overview
- Phase
- Phase 1
- Intervention
- Reference Drug or Test Drug
- Conditions
- Healthy
- Sponsor
- JW Pharmaceutical
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
- To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
- To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers
Exclusion Criteria
- •Subjects does not meet the Inclusion Criteria
Arms & Interventions
Group 1
Test Drug for Period I Reference Drug for Period II
Intervention: Reference Drug or Test Drug
Group 2
Reference Drug for Period I Test Drug for Period II
Intervention: Reference Drug or Test Drug
Outcomes
Primary Outcomes
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
Time Frame: 0 ~ 24h
Evaluation PK for Esomeprazole after multiple dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
Time Frame: Baseline versus Multiple dose during 7 days
Evaluation PD for ambulatory 24hr pH monitor