Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361277
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-03-27
Brief Title:
To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers
Sponsor:
JW Pharmaceutical
Organization:
JW Pharmaceutical
Study Overview
Official Title:
A Randomized Open-label Single Dose Crossover Study to Compare the Pharmacokinetic Characteristics and Safety of JW0202 and C2202 or C2205 and JW0201 After Oral Administration in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions
Detailed Description:
Pharmacokinetic characteristics Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group
Safety All adverse events are summarized in terms of the number of subjects expression rate and number of expressions of adverse reactions by treatment group
Safety All adverse events are summarized in terms of the number of subjects expression rate and number of expressions of adverse reactions by treatment group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None