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

NCT05433844 | Completed Phase 1

• 1 other identifier: JW21103
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. 2.To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Evaluation PK for Esomeprazole after multiple dose

  0 ~ 24h

• 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

Study Arms (2)

Group 1

OTHER

Test Drug for Period I Reference Drug for Period II

Drug: Reference Drug or Test Drug

Group 2

OTHER

Reference Drug for Period I Test Drug for Period II

Drug: Reference Drug or Test Drug

Interventions

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

Also known as: Reference Drug(C2105) or Test Drug(JW0301)

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• SeungHwan Lee, PI

  Clinical Trial Center, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 27, 2022
• Study Start: June 2, 2022
• Primary Completion: August 26, 2022
• Study Completion: September 14, 2022
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)