NCT02579356

To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Samil Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a day for 6 days.

Conditions

• Diseases of the Circulatory System
• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Telmisartan
DRUG	Atorvastatin

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2015-10-19
• Last updated: 2015-10-19

Locations

1 site across 1 country: South Korea