NCT02387619

The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Jeil Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Detailed description

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Rosuvastatin	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
DRUG	Telmisartan/Amlodipine	Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
DRUG	Rosuvastatin and Telmisartan/Amlodipine	Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-03-01
• Completion: 2015-07-01
• First posted: 2015-03-13
• Last updated: 2016-06-24

Locations

1 site across 1 country: South Korea