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Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers

Hypertension Clinical Trial

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 80/2.5mg" and "TWYNSTA Tablet 80/5mg" in Healthy Adult Volunteers

Clinical Trial 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 80/2.5mg(telmisartan/s-amlodipine)" and "TWINSTA tablet 80/5mg(telmisartan/amlodipine)" in healthy adult volunteers.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04667624
Study type Interventional
Source Hanlim Pharm. Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date February 29, 2020
Completion date May 18, 2020
View Details
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