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OpenTrials
Completed

NCT Number: NCT05433844

To Evaluate the PK, PD, Safety and Drug Tolerance 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

About this study

  • 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.

  • All subjects who received more than one dose of clinical trial drugs are evaluated.

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

Reference Drug or Test Drug

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

Other names: Reference Drug(C2105) or Test Drug(JW0301)

Primary outcomes

  1. AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)

    Time frame: 0 ~ 24h

    Evaluation PK for Esomeprazole after multiple dose

  2. 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 of JW0301 to C2105 in Healthy Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Mar 21, 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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