drugset / Trial / NCT04667624
Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2020-02-29
- Primary completion
- 2020-04-28
- Completion
- 2020-05-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | 5 mg | Oral |
| Subject | S-amlodipine | Unknown | 2.5 mg | Oral |
| Comparator | Telmisartan | Other / unclassified | 80 mg | Oral |