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

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteers

Exclusion criteria

Subjects does not meet the Inclusion Criteria

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Mar 24, 2023
Registry last updated: Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed