To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers
Sponsor
JW Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05433844
Collaborator
(none)
44
1
2
9
4.9
Study Details
Study Description
Brief Summary
-
To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
-
To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
44 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
A randomized, open, single-dose, 2x2 crossover-design clinical trialA randomized, open, single-dose, 2x2 crossover-design clinical trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Anticipated Study Start Date
:
Jun 1, 2022
Anticipated Primary Completion Date
:
Sep 1, 2022
Anticipated Study Completion Date
:
Mar 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Group 1 Test Drug for Period I Reference Drug for Period II |
Drug: Reference 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
|
| Other: Group 2 Reference Drug for Period I Test Drug for Period II |
Drug: Reference 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
|
Outcome Measures
Primary Outcome Measures
- AUCĪ, 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Subjects does not meet the Inclusion Criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Trial Center, Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- JW Pharmaceutical
Investigators
- Principal Investigator: SeungHwan Lee, PI, Clinical Trial Center, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT05433844
Other Study ID Numbers:
- JW21103
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No