Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667624
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2020-12-08
Brief Title:
Study to Evaluate the Safety and PK of LODIENT Tablet 8025mg in Healthy Adult Volunteers
Sponsor:
Hanlim Pharm Co Ltd
Organization:
Hanlim Pharm Co Ltd
Study Overview
Official Title:
A Randomized Open Label Single Dose 2-sequence 4-period Cross-over Phase I Clinical Trial to Compare and Evaluate the Safety and PK After Oral Administration of LodienT Tablet 8025mg and TWYNSTA Tablet 805mg in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2020-12
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:
A randomized open label single dose 2-sequence 4-period cross-over phase I clinical trial to compare and evaluate the safety and pharmacokinetics after oral administration of LodienT tablet 8025mgtelmisartans-amlodipine and TWINSTA tablet 805mgtelmisartanamlodipine in healthy adult volunteers
Detailed Description:
Amlodipine is a drug which belongs to calcium channel blockers CCBs and is used to treat hypertension The molecule contains one chiral carbon atom and exists as a racemic mixture As only the S-enantiomer of amlodipine S-amlodipine shows the CCB effect and R-amlodipine is responsible for the development of peripheral edema purifying S-amlodipine can reduce the incidences of peripheral edema and other side effects
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