The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.
• Treatments: Amlodipine; Rosuvastatin Calcium; Telmisartan; Telmisartan amlodipine combination

Criteria

Inclusion Criteria:

• 19~55 years healthy male

• Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2

• Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

• Subjects who are allergic to investigational drug.

• Subjects who have a medical history which can affect the clinical trial.

• Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)

• Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.