NCT05784155
Completed
Phase 1
A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult Subjects
JW Pharmaceutical1 site in 1 country44 target enrollmentMarch 10, 2023
ConditionsHealthy
InterventionsTest Drug(JW0302) or Reference Drug(C2206)
Overview
- Phase
- Phase 1
- Intervention
- Test Drug(JW0302) or Reference Drug(C2206)
- 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
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: Test Drug(JW0302) or Reference Drug(C2206)
Group 2
Reference Drug for Period I Test Drug for Period II
Intervention: Test Drug(JW0302) or Reference Drug(C2206)
Outcomes
Primary Outcomes
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
Time Frame: up to 24 hours
Evaluation PK for JW0302 and C2206 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
Study Sites (1)
Loading locations...
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