Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04601766
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2020-10-20
Brief Title:
A Phase I Two-phase Crossover Study to Evaluate the Safety Tolerability and Pharmacokinetics of APL-1501 ER Tablets
Sponsor:
Asieris Pharmaceuticals AUS Pty Ltd
Organization:
Jiangsu Yahong Meditech Co Ltd aka Asieris
Study Overview
Official Title:
A Phase I Open-Label Randomized Two-phase Crossover Study to Evaluate the Safety Tolerability and Pharmacokinetics of APL-1501 ER Tablets 2 APL1501 ER Tablets 3 and APL-1202 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2020-10
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:
A two-phase study design will be used for this pilot study In the first phase a 22 crossover study will be used to evaluate the safety tolerability and PK characteristic of APL-1202 and APL-1501 ER Tablets 3 Twelve healthy subjects will be in ratio 11 randomly assigned to two groups randomization will be stratified by gender male female in ratio 11 Each group will be dosed with APL-1202 APL-1501 ER Tablets 3 in a cross-over way A 7-day 1 day washout will be required before next period of drug administration The samples in first phase will be sent to bioanalysis lab for PK research at the end of first phase The initiate of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase
Detailed Description:
None
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