NCT02047175

CKD-346 DDI Study(Telmisartan/S-Amlodipine, Rosuvastatin)

A Randomized, Open-label, Multiple-dose, Two-arm, One-sequence • Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration Telmisartan/S-amlodipine and Rosuvastatin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the drug-drug interaction of CKD-346(Telmisartan/S-Amlodipine, Rosuvastatin)

Detailed description

A randomized, open-label, multiple-dose, two-arm, one-sequence · crossover study to evaluate the safety and pharmacokinetics after oral concurrent administration telmisartan/s-amlodipine and rosuvastatin in healthy volunteers.

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Telmisartan/S-Amlodipine	Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days
DRUG	Rosuvastatin	Rosuvastatin 20mg 1T PO, QD for 5days
DRUG	Telmisartan/S-Amlodipine + Rosuvastatin	Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days
DRUG	Telmisartan/S-Amlodipine + Rosuvastatin	Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-01-28
• Last updated: 2014-04-17

Locations

1 site across 1 country: South Korea