Healthy Clinical Trial
Official title:
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
Verified date | March 2024 |
Source | JW Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 44 |
Est. completion date | June 26, 2023 |
Est. primary completion date | June 9, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 55 Years |
Eligibility | Inclusion Criteria: - Healthy volunteers Exclusion Criteria: - Subjects does not meet the Inclusion Criteria |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Clinical Trial Center, Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
JW Pharmaceutical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUCt, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state) | Evaluation PK for JW0302 and C2206 after multiple dose | up to 24 hours | |
Primary | Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose | Evaluation PD for ambulatory 24hr pH monitor | Baseline versus Multiple dose during 7 days |
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