To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

NCT05784155 — Phase 1, Completed, 44 participants, JW Pharmaceutical

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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

Registry	NCT05784155
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: none, other
Enrollment	44 (Actual)
Sponsor	JW Pharmaceutical (Industry)
Conditions	Healthy
Interventions	Test Drug(JW0302) or Reference Drug(C2206) (Drug)
Dates	start 2023-03-10, primary completion 2023-06-09, completion 2023-06-26, first posted 2023-03-24, last updated 2024-03-20
Locations	1 site in South Korea

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Other	Drug: Test Drug(JW0302) or Reference Drug(C2206)	Test Drug for Period I Reference Drug for Period II
Group 2	Other	Drug: Test Drug(JW0302) or Reference Drug(C2206)	Reference Drug for Period I Test Drug for Period II

Test Drug(JW0302) or Reference Drug(C2206) (Drug): Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

+Outcome measures

Primary outcomes

AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state) [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 [Baseline versus Multiple dose during 7 days]: Evaluation PD for ambulatory 24hr pH monitor

+Eligibility

Sex: All, ages: 19 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

+Locations (1)

Facility	City	Country	Status
Clinical Trial Center, Seoul National University Hospital	Seoul	South Korea

+Investigators

SeungHwan Lee, PI, Principal investigator, Clinical Trial Center, Seoul National University Hospital