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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05433844

Enrollment

Registered

2022-06-27

Start date

2022-06-02

Completion date

2022-09-14

Last updated

2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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

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.

Interventions

DRUGReference Drug or Test Drug

Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Intervention model description

A randomized, open, single-dose, 2x2 crossover-design clinical trial

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Subjects does not meet the Inclusion Criteria

Design outcomes

Primary

Measure	Time frame	Description
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)	0 ~ 24h	Evaluation PK for Esomeprazole 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026