A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase 1, open label, two-cohort, single-sequence, crossover study

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Amlodipine; Rosuvastatin Calcium; Telmisartan; Telmisartan amlodipine combination

Criteria

Inclusion Criteria:

• Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2

• Who has not suffered from clinically significant disease

• Provision of signed written informed consent

Exclusion Criteria:

• History of and clinically significant disease

• A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs

• Administration of other investigational products within 3 months prior to the first dosing

• Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

• Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)