Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
Study NCT ID:
NCT04886050
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2021-05-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults
Sponsor:
LG Chem
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Bioavailability of an LC350189 Tablet Relative to an LC350189 Capsule in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-12
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:
This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the relative bioavailability of LC350189 after administration via tablet formulation compared with capsule formulation and to evaluate basic systemic pharmacokinetic parameters of the tablet formulation compared to the capsule formulation of LC350189.
Detailed Description:
None
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?: