Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04313205
Status:
UNKNOWN
Last Update Posted:
2020-07-15
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
Sponsor:
TaiwanJ Pharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
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 purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.
Detailed Description:
This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. After screening, subjects will be randomized to receive either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a washout period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: